Catheter, Angioplasty, Peripheral, Transluminal
FDA product code LIT · 374 cleared devices
Class 2
Cardiovascular
- Regulation
- 21 CFR 870.1250
- Review panel
- CV
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1981-01-13 – 2026-09-21
LIT
2026-09-21
LIT
2026-09-16
NC PTA Balloon Dilatation Catheter
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LIT
2026-05-20
WAVE PTA Balloon Catheter
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LIT
2026-02-13
Armada™ 14 NC PTA Catheter
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LIT
2025-12-18
Amethyst HP PTA OTW 0.035 Catheter
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LIT
2025-04-04
Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter
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LIT
2025-02-27
Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter
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LIT
2024-12-18
Amethyst HP PTA OTW 0.035 Catheter
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LIT
2024-11-15
018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter
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LIT
2024-07-16
Finesse Injectable™ PTA Balloon Dilatation Catheter
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LIT
2024-07-11
Oscar Peripheral Multifunctional Catheter system
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LIT
2024-07-10
Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031406020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031408020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031410020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031412020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031415020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H749390314
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LIT
2024-06-11
JADE PLUS PTA Balloon Dilatation Catheter
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LIT
2023-12-20
HP PTA Balloon Dilatation Catheter
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LIT
2023-05-26
Finesse™ Injectable PTA Balloon Dilatation Catheter
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LIT
2023-04-05
D·Kaptain PTA High Pressure Balloon Dilatation Catheter
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LIT
2023-03-22
Arise™ UHP Dilatation Catheter
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LIT
2023-02-16
Passeo-35 Xeo Peripheral Dilatation Catheter
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LIT
2023-01-20
Highlander™ 014 PTA Balloon Dilatation Catheter
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LIT
2022-12-14
PTA Balloon Dilatation Catheter
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LIT
2022-09-02
ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter
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LIT
2022-08-22
SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter
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LIT
2022-07-19
Tiche PTA Balloon Dilatation Catheter
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LIT
2022-07-06
Oscar Peripheral Multifunctional Catheter system
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LIT
2022-06-29
Ebony HP PTA OTW 0.035 Catheter
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LIT
2022-06-09
Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection
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LIT
2022-05-05
Viatrac 14 Plus Peripheral Dilatation Catheter
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LIT
2021-12-15
Chocolate PTA Balloon Catheter
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LIT
2021-08-03
PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ)
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LIT
2021-06-16
Sublime Radial Access 018 RX Dilatation Catheter
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LIT
2021-04-23
SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter
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LIT
2020-12-10
JADE
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LIT
2020-11-18
Pacific Plus PTA Catheter
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LIT
2020-10-09
SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter
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LIT
2020-09-15
Athletis PTA Balloon Dilatation Catheter
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LIT
2020-09-11
SABER .035 PTA Dilatation Catheter
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LIT
2020-07-28
Jade
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LIT
2020-05-20
Infinity Angioplasty Balloon Catheter
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LIT
2020-05-14
Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter
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LIT
2020-01-15
All’InCath 035M PTA Balloon Dilatation Catheter
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LIT
2019-11-26
Advocate PTA Catheter
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LIT
2019-10-24
Cronus HP PTA Balloon Catheter
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LIT
2019-10-03
Ultraverse 014 and 018 PTA Balloon Dilatation Catheters
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LIT
2019-04-23
EverCrossTM 0.035 OTW PTA Dilatation Catheter
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LIT
2018-12-06
Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection
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LIT
2018-09-06
Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System)
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LIT
2018-08-03
Atlas Gold PTA Dilatation Catheter
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LIT
2018-04-19
018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter
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LIT
2018-04-12
Admiral Xtreme
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LIT
2018-02-09
Jade PTA Balloon Dilatation Catheter
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LIT
2017-12-15
PROTEUS PTA Balloon Catheter with Embolic Capture Feature
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LIT
2017-12-13
Advocate PTA Catheter
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LIT
2017-09-08
014 Hydrophilic Coated PTA Balloon Dilatation Catheter
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LIT
2017-08-31
Pirouette High Pressure (HP)
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LIT
2017-07-19
Vela RX PTA Balloon Dilatation Catheter
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LIT
2017-03-30
Chameleon PTA Balloon Catheter
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LIT
2017-02-13
Advance 14LP Low Profile PTA Balloon Dilatation Catheter
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LIT
2017-01-17
Chameleon PTA Balloon Catheter
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LIT
2017-01-11
R2P Metacross RX
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LIT
2016-12-13
Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter
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LIT
2016-11-22
Pirouette 014
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LIT
2016-11-04
Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018
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LIT
2016-07-30
Pirouette 035
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LIT
2016-07-29
Polux , Minerva and Atropos PTA Balloon Dilatation Catheter
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LIT
2016-04-29
Crosperio OTW
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LIT
2016-04-29
Crosstella OTW
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LIT
2016-04-25
MMS PTA Balloon Catheter
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LIT
2016-01-22
Crosperio RX PTA Balloon Dilatation Catheter
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LIT
2016-01-22
Crosstella RX Balloon Dilatation Catheter
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LIT
2016-01-14
Cronus HP - High Pressure Peripheral Balloon Catheter
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LIT
2013-12-06
PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE
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LIT
2013-10-25
ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER
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LIT
2013-10-17
STERLING OVER-THE-WIRE (OTW) PTA BALLOON DILATATION CATHETER
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LIT
2013-09-26
NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETER
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LIT
2013-06-20
ARROW GPSCATH BALLOON DILATATION CATHETER
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LIT
2013-06-15
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018
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LIT
2013-06-06
VECTOR PTA BALLOON DILATATION CATHETER
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LIT
2013-05-31
ADVANCE 18LP LOW PROFILE PTA BALLOON DILATATION CATHETER
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LIT
2013-05-30
ULTRAVERSE RX PTA BALLOON DILATATION CATHETER
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LIT
2013-05-24
RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER
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LIT
2013-05-03
SLEEK OTW PTA CATHETER
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LIT
2013-04-23
PASSEO-35
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LIT
2013-02-12
RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER
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LIT
2013-01-29
PACIFIC PLUS
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LIT
2012-10-22
ATLAS GOLD PTA DILATATION CATHETER
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LIT
2012-09-05
FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON DILATATION CATHETER - 4MM X 19MM X 135CM
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LIT
2012-08-15
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.18 G
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LIT
2012-07-11
ULTRAVERSE 014 AND 018 PTA BALLOON DILATATION CATHETERS LINE EXTENSION
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LIT
2012-06-29
FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CM
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LIT
2012-06-14
POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER
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LIT
2012-06-14
VECTOR
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LIT
2012-06-08
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018' G
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LIT
2012-06-08
PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE
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LIT
2012-05-22
AMPHIRION PLUS PTA CATHETER
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LIT
2012-05-04
POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER
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LIT
2012-04-19
ATLAS PTA BALLOON DILATATION CATHETER
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LIT
2012-04-19
RIVAL PTA DILATATION CATHETER
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LIT
2012-04-13
PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE
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LIT
2012-03-29
FLASH PTA BALLOON DILATATION CATHETER-4.0X14MMX135CM
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LIT
2012-03-15
CHOCOLATE PTA BALLON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014)
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