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FDA 510(k)

ASI HEMOSTASIS CATHETER

K-Number: K901336 · 1990-06-20

ApplicantAdvanced Surgical Intervention, Inc.
Decision Date1990-06-20
Product CodeGBM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ASI HEMOSTASIS CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Surgical Intervention, Inc.. It received FDA 510(k) clearance on 1990-06-20 under 510(k) number K901336. 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 ASI HEMOSTASIS CATHETER?

ASI HEMOSTASIS CATHETER is a medical device that received FDA 510(k) clearance on 1990-06-20. The listed applicant is Advanced Surgical Intervention, Inc.. The 510(k) number is K901336.

When did ASI HEMOSTASIS CATHETER receive FDA 510(k) clearance?

ASI HEMOSTASIS CATHETER received FDA 510(k) clearance on 1990-06-20, under 510(k) number K901336.

Who is the listed applicant for ASI HEMOSTASIS CATHETER?

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

What is the FDA product code for ASI HEMOSTASIS CATHETER?

The FDA product code for ASI HEMOSTASIS CATHETER is GBM.

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Other records listing Advanced Surgical Intervention, Inc. as applicant

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.

K954215MINIGUARDK926110ASI LIGASURE(TM) SUTURE LIGATION INSTRUMENTK930361ASI CYSTOLASE LASER CYSTOSCOPEK921990ASI UROPLASTY LASER CYSTOSCOPEK902585UROPLASTY TCU PROSTATIC URETHROPLASTY CATHETERK896713ASI TCU PROSTATIC URETHROPLASTY CATHETER & ACCESS.

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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 LimitedK211436Intermittent Catheter (Not Finalized)Hollister IncorporatedK200820SpeediCath Compact SetColoplastK192904SpeediCath Compact SetColoplastK200142SpeediCath SoftColoplast

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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