FDA 510(k)

ASTA-CATH

K-Number: K961361 · 1996-10-31

Decision Date1996-10-31

Product CodeGBM

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

ASTA-CATH is the device name listed in this FDA 510(k) record. The listed applicant is A+ Products. It received FDA 510(k) clearance on 1996-10-31 under 510(k) number K961361. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASTA-CATH?

ASTA-CATH is a medical device that received FDA 510(k) clearance on 1996-10-31. The listed applicant is A+ Products. The 510(k) number is K961361.

When did ASTA-CATH receive FDA 510(k) clearance?

ASTA-CATH received FDA 510(k) clearance on 1996-10-31, under 510(k) number K961361.

Who is the listed applicant for ASTA-CATH?

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

What is the FDA product code for ASTA-CATH?

The FDA product code for ASTA-CATH is GBM.

Related Devices (Code: GBM)

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.

K241734Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter CompactWell Lead Medical Co., Ltd.K213283GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterConvatec Limited K211436Intermittent Catheter (Not Finalized)Hollister Incorporated K200820SpeediCath Compact SetColoplast K192904SpeediCath Compact SetColoplast K200142SpeediCath SoftColoplast

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.