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FDA 510(k)

ACCEMT DG(TM) BALLOON ANGIOPLASTY CATH, MODIFIED

K-Number: K924358 · 1993-05-20

ApplicantCook, Inc.
Decision Date1993-05-20
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACCEMT DG(TM) BALLOON ANGIOPLASTY CATH, MODIFIED is the device name listed in this FDA 510(k) record. The listed applicant is Cook, Inc.. It received FDA 510(k) clearance on 1993-05-20 under 510(k) number K924358. 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 ACCEMT DG(TM) BALLOON ANGIOPLASTY CATH, MODIFIED?

ACCEMT DG(TM) BALLOON ANGIOPLASTY CATH, MODIFIED is a medical device that received FDA 510(k) clearance on 1993-05-20. The listed applicant is Cook, Inc.. The 510(k) number is K924358.

When did ACCEMT DG(TM) BALLOON ANGIOPLASTY CATH, MODIFIED receive FDA 510(k) clearance?

ACCEMT DG(TM) BALLOON ANGIOPLASTY CATH, MODIFIED received FDA 510(k) clearance on 1993-05-20, under 510(k) number K924358.

Who is the listed applicant for ACCEMT DG(TM) BALLOON ANGIOPLASTY CATH, MODIFIED?

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

What is the FDA product code for ACCEMT DG(TM) BALLOON ANGIOPLASTY CATH, MODIFIED?

The FDA product code for ACCEMT DG(TM) BALLOON ANGIOPLASTY CATH, MODIFIED is LIT.

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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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