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FDA 510(k)

MODIFIED TRANSLUMINAL BALLOON DILATATION CATHETERS

K-Number: K901018 · 1990-05-30

ApplicantBoston Scientific Corp
Decision Date1990-05-30
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFIED TRANSLUMINAL BALLOON DILATATION CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 1990-05-30 under 510(k) number K901018. 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 MODIFIED TRANSLUMINAL BALLOON DILATATION CATHETERS?

MODIFIED TRANSLUMINAL BALLOON DILATATION CATHETERS is a medical device that received FDA 510(k) clearance on 1990-05-30. The listed applicant is Boston Scientific Corp. The 510(k) number is K901018.

When did MODIFIED TRANSLUMINAL BALLOON DILATATION CATHETERS receive FDA 510(k) clearance?

MODIFIED TRANSLUMINAL BALLOON DILATATION CATHETERS received FDA 510(k) clearance on 1990-05-30, under 510(k) number K901018.

Who is the listed applicant for MODIFIED TRANSLUMINAL BALLOON DILATATION CATHETERS?

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

What is the FDA product code for MODIFIED TRANSLUMINAL BALLOON DILATATION CATHETERS?

The FDA product code for MODIFIED TRANSLUMINAL BALLOON DILATATION CATHETERS is LIT.

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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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