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FDA 510(k)

PASSEO-35 PTA CATHETER

K-Number: K082933 · 2008-11-03

ApplicantBiotronik, Inc.
Decision Date2008-11-03
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PASSEO-35 PTA CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 2008-11-03 under 510(k) number K082933. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PASSEO-35 PTA CATHETER?

PASSEO-35 PTA CATHETER is a medical device that received FDA 510(k) clearance on 2008-11-03. The listed applicant is Biotronik, Inc.. The 510(k) number is K082933.

When did PASSEO-35 PTA CATHETER receive FDA 510(k) clearance?

PASSEO-35 PTA CATHETER received FDA 510(k) clearance on 2008-11-03, under 510(k) number K082933.

Who is the listed applicant for PASSEO-35 PTA CATHETER?

The FDA 510(k) record lists Biotronik, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PASSEO-35 PTA CATHETER?

The FDA product code for PASSEO-35 PTA CATHETER is DQY.

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Other records listing Biotronik, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261074BIOMONITOR IV (471155)K250706Passeo-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) CatheterK242969Pantera Pro; Pantera LEOK240787Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518)K241711Oscar Peripheral Multifunctional Catheter systemK230375BIOMONITOR IV

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Related Devices (Code: DQY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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