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FDA 510(k)

ANTIMICROBIAL FOLEY CATHETER

K-Number: K871429 · 1987-08-10

ApplicantAmerican Pharmaseal Div. Ahsc
Decision Date1987-08-10
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ANTIMICROBIAL FOLEY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is American Pharmaseal Div. Ahsc. It received FDA 510(k) clearance on 1987-08-10 under 510(k) number K871429. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTIMICROBIAL FOLEY CATHETER?

ANTIMICROBIAL FOLEY CATHETER is a medical device that received FDA 510(k) clearance on 1987-08-10. The listed applicant is American Pharmaseal Div. Ahsc. The 510(k) number is K871429.

When did ANTIMICROBIAL FOLEY CATHETER receive FDA 510(k) clearance?

ANTIMICROBIAL FOLEY CATHETER received FDA 510(k) clearance on 1987-08-10, under 510(k) number K871429.

Who is the listed applicant for ANTIMICROBIAL FOLEY CATHETER?

The FDA 510(k) record lists American Pharmaseal Div. Ahsc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANTIMICROBIAL FOLEY CATHETER?

The FDA product code for ANTIMICROBIAL FOLEY CATHETER is KOD.

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Other records listing American Pharmaseal Div. Ahsc 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.

K874022PHARMASEAL WOUND IRRIGATION DEVICEK874517PHARMASEAL RUBBER URETHRAL CATHETERK874045PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWERK873359AIRLIFE VOLUME VENTI. CIRCUIT W/CLEAR CAP EX VALVEK872228PHARMASEAL ALTERNATING PRESSURE PAD SYSTEMK872917JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER

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Related Devices (Code: KOD)

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.

K251864Rubber Utility CatheterC.R. Bard, Inc.K220036Wellead Ureteral CatheterWell Lead Medical Co., Ltd.K220730allFlex Ureteral Catheters, Krait Ureteral CathetersAllwin Medical Devices, Inc.K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd.K181979Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterTeleflexmedical, Inc.K180354UroGen Ureteral CatheterUrogen Pharma, Ltd.

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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