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FDA 510(k)

PHARM 100% SILICONE FOLEY CATH TEMPERATURE PROBE

K-Number: K853207 · 1985-09-12

ApplicantAmerican Pharmaseal Div. Ahsc
Decision Date1985-09-12
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PHARM 100% SILICONE FOLEY CATH TEMPERATURE PROBE 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 1985-09-12 under 510(k) number K853207. 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 PHARM 100% SILICONE FOLEY CATH TEMPERATURE PROBE?

PHARM 100% SILICONE FOLEY CATH TEMPERATURE PROBE is a medical device that received FDA 510(k) clearance on 1985-09-12. The listed applicant is American Pharmaseal Div. Ahsc. The 510(k) number is K853207.

When did PHARM 100% SILICONE FOLEY CATH TEMPERATURE PROBE receive FDA 510(k) clearance?

PHARM 100% SILICONE FOLEY CATH TEMPERATURE PROBE received FDA 510(k) clearance on 1985-09-12, under 510(k) number K853207.

Who is the listed applicant for PHARM 100% SILICONE FOLEY CATH TEMPERATURE PROBE?

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 PHARM 100% SILICONE FOLEY CATH TEMPERATURE PROBE?

The FDA product code for PHARM 100% SILICONE FOLEY CATH TEMPERATURE PROBE is KOD.

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Other records listing American Pharmaseal Div. Ahsc as applicant

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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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