FDA 510(k)

BARD TAPERSEAL INTRA-AORTIC BALLOON CATHETER & INTRODUCER KIT

K-Number: K962177 · 1996-09-04

Decision Date1996-09-04

Product CodeDSP

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

BARD TAPERSEAL INTRA-AORTIC BALLOON CATHETER & INTRODUCER KIT is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 1996-09-04 under 510(k) number K962177. The device is classified under product code DSP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BARD TAPERSEAL INTRA-AORTIC BALLOON CATHETER & INTRODUCER KIT?

BARD TAPERSEAL INTRA-AORTIC BALLOON CATHETER & INTRODUCER KIT is a medical device that received FDA 510(k) clearance on 1996-09-04. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K962177.

When did BARD TAPERSEAL INTRA-AORTIC BALLOON CATHETER & INTRODUCER KIT receive FDA 510(k) clearance?

BARD TAPERSEAL INTRA-AORTIC BALLOON CATHETER & INTRODUCER KIT received FDA 510(k) clearance on 1996-09-04, under 510(k) number K962177.

Who is the listed applicant for BARD TAPERSEAL INTRA-AORTIC BALLOON CATHETER & INTRODUCER KIT?

The FDA 510(k) record lists C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BARD TAPERSEAL INTRA-AORTIC BALLOON CATHETER & INTRODUCER KIT?

The FDA product code for BARD TAPERSEAL INTRA-AORTIC BALLOON CATHETER & INTRODUCER KIT is DSP.

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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.