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FDA 510(k)

VECTOR PTA BALLOON DILATATION CATHETER

K-Number: K131329 · 2013-06-06

ApplicantR4 Vascular, Inc.
Decision Date2013-06-06
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VECTOR PTA BALLOON DILATATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is R4 Vascular, Inc.. It received FDA 510(k) clearance on 2013-06-06 under 510(k) number K131329. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VECTOR PTA BALLOON DILATATION CATHETER?

VECTOR PTA BALLOON DILATATION CATHETER is a medical device that received FDA 510(k) clearance on 2013-06-06. The listed applicant is R4 Vascular, Inc.. The 510(k) number is K131329.

When did VECTOR PTA BALLOON DILATATION CATHETER receive FDA 510(k) clearance?

VECTOR PTA BALLOON DILATATION CATHETER received FDA 510(k) clearance on 2013-06-06, under 510(k) number K131329.

Who is the listed applicant for VECTOR PTA BALLOON DILATATION CATHETER?

The FDA 510(k) record lists R4 Vascular, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VECTOR PTA BALLOON DILATATION CATHETER?

The FDA product code for VECTOR PTA BALLOON DILATATION CATHETER is LIT.

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Other records listing R4 Vascular, 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.

K121385VECTORK100169DURASPAN HEMODIALYSIS LONG-TERM CATHETERK091506DURASPAN HEMODIALYSIS LONG-TERM CATHETER, MODELS 62152420, 621512820, 62153220, 62153620, 62154020, 62155520K092040PHEROCIOUS 10.5 FR (24 CM, 28 CM AND 32 CM), MODELS 430102440, 430102840, 430103240K083763ZEUS CT PICC 4 FR AND 5 FR SINGLE AND DUAL LUMENK071361R4 VASCULAR INC. PEGASUS CT PICC, MODEL 500005-001,002, 004, 005, 500004-001, 002,004,005

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Related Devices (Code: LIT)

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.

K260416ZYLOX Hippo PTA Balloon Dilatation CatheterZylox Medtech Co., Ltd.K254212NC PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.K260304WAVE PTA Balloon CatheterWAVE Medical AGK252512Armada™ 14 NC PTA CatheterABBOTT MEDICALK251915Amethyst HP PTA OTW 0.035 CatheterNatec Medical , Ltd.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) CatheterBiotronik, Inc.

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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