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FDA 510(k)

SCIMED VIPER CATHETER

K-Number: K915347 · 1992-08-17

ApplicantScimed
Decision Date1992-08-17
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SCIMED VIPER CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Scimed. It received FDA 510(k) clearance on 1992-08-17 under 510(k) number K915347. 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 VIPER CATHETER?

SCIMED VIPER CATHETER is a medical device that received FDA 510(k) clearance on 1992-08-17. The listed applicant is Scimed. The 510(k) number is K915347.

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

SCIMED VIPER CATHETER received FDA 510(k) clearance on 1992-08-17, under 510(k) number K915347.

Who is the listed applicant for SCIMED VIPER CATHETER?

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

What is the FDA product code for SCIMED VIPER CATHETER?

The FDA product code for SCIMED VIPER CATHETER is LIT.

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Other records listing Scimed 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.

K992142SCIMED ANGIOGRAPHIC CATHETERSK953909SCIMED 6 FRENCH MICRO-MAX GUIDE CATHETERK931584SCIMED TRANSPORT STEERABLE GUIDE WIRE AND ACCESS.K922706SCIMED SIDELINERK9109877FR. AND 8FR. TRIGUIDE GUIDING CATHETER ADD. CURVEK904171SCIMED CARDIOTHERM CARDIOPLEGIA DELIVERY SYSTEM

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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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