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FDA 510(k)

CORPAK FOLEY CATH TRAY W/16FR. TEFLON

K-Number: K841819 · 1984-07-19

ApplicantCorpak Co.
Decision Date1984-07-19
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CORPAK FOLEY CATH TRAY W/16FR. TEFLON is the device name listed in this FDA 510(k) record. The listed applicant is Corpak Co.. It received FDA 510(k) clearance on 1984-07-19 under 510(k) number K841819. 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 CORPAK FOLEY CATH TRAY W/16FR. TEFLON?

CORPAK FOLEY CATH TRAY W/16FR. TEFLON is a medical device that received FDA 510(k) clearance on 1984-07-19. The listed applicant is Corpak Co.. The 510(k) number is K841819.

When did CORPAK FOLEY CATH TRAY W/16FR. TEFLON receive FDA 510(k) clearance?

CORPAK FOLEY CATH TRAY W/16FR. TEFLON received FDA 510(k) clearance on 1984-07-19, under 510(k) number K841819.

Who is the listed applicant for CORPAK FOLEY CATH TRAY W/16FR. TEFLON?

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

What is the FDA product code for CORPAK FOLEY CATH TRAY W/16FR. TEFLON?

The FDA product code for CORPAK FOLEY CATH TRAY W/16FR. TEFLON is KOD.

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Other records listing Corpak Co. 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.

K935512CORPAK REPLACEMENT GASTROSTOMY DEVICE STOMACOREK931921CORPAK GASTROSTOMY TUBEK932847CORPAK ENTERAL PUMPK902949CORPAK GRASPING FORCEPSK901501CORPAK GASTROSTOMY TUBEK882867CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE

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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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