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FDA 510(k)

OPTI-PLAST XL 5.5 F PTA CATHETER

K-Number: K970725 · 1997-05-09

ApplicantVas-Cath, Inc.
Decision Date1997-05-09
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OPTI-PLAST XL 5.5 F PTA CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Vas-Cath, Inc.. It received FDA 510(k) clearance on 1997-05-09 under 510(k) number K970725. 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 OPTI-PLAST XL 5.5 F PTA CATHETER?

OPTI-PLAST XL 5.5 F PTA CATHETER is a medical device that received FDA 510(k) clearance on 1997-05-09. The listed applicant is Vas-Cath, Inc.. The 510(k) number is K970725.

When did OPTI-PLAST XL 5.5 F PTA CATHETER receive FDA 510(k) clearance?

OPTI-PLAST XL 5.5 F PTA CATHETER received FDA 510(k) clearance on 1997-05-09, under 510(k) number K970725.

Who is the listed applicant for OPTI-PLAST XL 5.5 F PTA CATHETER?

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

What is the FDA product code for OPTI-PLAST XL 5.5 F PTA CATHETER?

The FDA product code for OPTI-PLAST XL 5.5 F PTA CATHETER is LIT.

Related Clinical Trials

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.

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Other records listing Vas-Cath, 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.

K973013OPTI-PLAST (CENTURION) 5.5F ANGIOPLASTY CATHETERK965178NIAGARA DUAL LUMEN CATHETERK964881ULTRAVERSE PTA CATHETERK941706OPTI-PLAST ANGIOPLASTY CATHETERK925485VAS-CATH INC. OPTI-PLAST ANGIOPLASTY CATHETERK933483OPTI-PLAST 5F PTA CATHETERS

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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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