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FDA 510(k)

TENCKHOFF CATHETER

K-Number: K801818 · 1980-10-23

ApplicantSil-Med Corp.
Decision Date1980-10-23
Product CodeFJS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TENCKHOFF CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Sil-Med Corp.. It received FDA 510(k) clearance on 1980-10-23 under 510(k) number K801818. The device is classified under product code FJS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TENCKHOFF CATHETER?

TENCKHOFF CATHETER is a medical device that received FDA 510(k) clearance on 1980-10-23. The listed applicant is Sil-Med Corp.. The 510(k) number is K801818.

When did TENCKHOFF CATHETER receive FDA 510(k) clearance?

TENCKHOFF CATHETER received FDA 510(k) clearance on 1980-10-23, under 510(k) number K801818.

Who is the listed applicant for TENCKHOFF CATHETER?

The FDA 510(k) record lists Sil-Med Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TENCKHOFF CATHETER?

The FDA product code for TENCKHOFF CATHETER is FJS.

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Other records listing Sil-Med Corp. 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.

K972521NAVIGATOR (STYLET) 2006K961392ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT IIK961194ANTIMICROBIAL MEDIASTINAL SILICONE DRAINK961295SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCARK960099PENROSE DRAIN MODELS 6001 - 6007K955463GRIP-A-BOOTS

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Related Devices (Code: FJS)

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.

K213602Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool KitCovidien, LLCK180485Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter ExtenderCovidien, LLCK130441FALLER STYLETMedionics International, Inc.K121383PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS)Medical Components, Inc.K120130FALLER TROCARMedigroup, Inc.K113354VETA PERITONEAL DIALYSIS CATHETERPfm Medical, Inc.

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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