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FDA 510(k)

CATHETER, RADIOPAQUE TENCKHOFF

K-Number: K782057 · 1979-02-27

ApplicantDravon Medical, Inc.
Decision Date1979-02-27
Product CodeFJS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CATHETER, RADIOPAQUE TENCKHOFF is the device name listed in this FDA 510(k) record. The listed applicant is Dravon Medical, Inc.. It received FDA 510(k) clearance on 1979-02-27 under 510(k) number K782057. 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 CATHETER, RADIOPAQUE TENCKHOFF?

CATHETER, RADIOPAQUE TENCKHOFF is a medical device that received FDA 510(k) clearance on 1979-02-27. The listed applicant is Dravon Medical, Inc.. The 510(k) number is K782057.

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

CATHETER, RADIOPAQUE TENCKHOFF received FDA 510(k) clearance on 1979-02-27, under 510(k) number K782057.

Who is the listed applicant for CATHETER, RADIOPAQUE TENCKHOFF?

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

What is the FDA product code for CATHETER, RADIOPAQUE TENCKHOFF?

The FDA product code for CATHETER, RADIOPAQUE TENCKHOFF is FJS.

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Other records listing Dravon Medical, 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.

K873455S3086 ARTERIAL, S3087 VENOUS NEONATAL HEMODIALYSISK860770AM-100 I/A AMPACK832739STEDIFLO INFUSION SETK831842DRAVON T CLAMPK812772PERITONEAL DIALYSIS CYCLER SET (8UNIT)K812771PERITONEAL DIALYSIS DRAINAGE

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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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