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FDA 510(k)

BLUE MAX II BALLOON DDILATATION CATHETER

K-Number: K921254 · 1992-12-03

ApplicantBoston Scientific Corp
Decision Date1992-12-03
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BLUE MAX II BALLOON DDILATATION CATHETER 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 1992-12-03 under 510(k) number K921254. 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 BLUE MAX II BALLOON DDILATATION CATHETER?

BLUE MAX II BALLOON DDILATATION CATHETER is a medical device that received FDA 510(k) clearance on 1992-12-03. The listed applicant is Boston Scientific Corp. The 510(k) number is K921254.

When did BLUE MAX II BALLOON DDILATATION CATHETER receive FDA 510(k) clearance?

BLUE MAX II BALLOON DDILATATION CATHETER received FDA 510(k) clearance on 1992-12-03, under 510(k) number K921254.

Who is the listed applicant for BLUE MAX II BALLOON DDILATATION CATHETER?

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 BLUE MAX II BALLOON DDILATATION CATHETER?

The FDA product code for BLUE MAX II BALLOON DDILATATION CATHETER 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

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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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