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FDA 510(k)

SCIMED MAVERICK PTA CATHETER

K-Number: K932537 · 1993-12-08

ApplicantScimed Life Systems, Inc.
Decision Date1993-12-08
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SCIMED MAVERICK PTA CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Scimed Life Systems, Inc.. It received FDA 510(k) clearance on 1993-12-08 under 510(k) number K932537. 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 SCIMED MAVERICK PTA CATHETER?

SCIMED MAVERICK PTA CATHETER is a medical device that received FDA 510(k) clearance on 1993-12-08. The listed applicant is Scimed Life Systems, Inc.. The 510(k) number is K932537.

When did SCIMED MAVERICK PTA CATHETER receive FDA 510(k) clearance?

SCIMED MAVERICK PTA CATHETER received FDA 510(k) clearance on 1993-12-08, under 510(k) number K932537.

Who is the listed applicant for SCIMED MAVERICK PTA CATHETER?

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

What is the FDA product code for SCIMED MAVERICK PTA CATHETER?

The FDA product code for SCIMED MAVERICK PTA CATHETER is LIT.

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Other records listing Scimed Life Systems, 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.

K974241SCIMED INFORMER PRESSURE WIRE SYSTEMK981788SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETERK980360SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRESK974559SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERSK974684SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETERK973945LUGE GUIDE WIRE

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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

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

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