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FDA 510(k)

SCIMED MAVERICK

K-Number: K934793 · 1994-01-05

ApplicantScimed Peripheral Interventions
Decision Date1994-01-05
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SCIMED MAVERICK is the device name listed in this FDA 510(k) record. The listed applicant is Scimed Peripheral Interventions. It received FDA 510(k) clearance on 1994-01-05 under 510(k) number K934793. 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?

SCIMED MAVERICK is a medical device that received FDA 510(k) clearance on 1994-01-05. The listed applicant is Scimed Peripheral Interventions. The 510(k) number is K934793.

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

SCIMED MAVERICK received FDA 510(k) clearance on 1994-01-05, under 510(k) number K934793.

Who is the listed applicant for SCIMED MAVERICK?

The FDA 510(k) record lists Scimed Peripheral Interventions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SCIMED MAVERICK?

The FDA product code for SCIMED MAVERICK is LIT.

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Other records listing Scimed Peripheral Interventions 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.

K945904SCIMED(R) VENTURE(TM) II INFUSION CATHETERK946272SCIMED(R) COURIER GUIDE CATHETERK944677SCIMED TRANSENT EX STEERABLE GUIDE WIRE AND ACCESSORIESK941710SCIMED TRANSEND STEERABLE GUIDE WIRE AND ACCESSORIESK935501SCIMED VIPER PTA CATHETER WITH BIOSLIDE HYDROPHILIC COATINGK934122SCIMED TRANSEND EX STEERABLE GUIDE WIRE AND ACCESSORIES

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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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