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FDA 510(k)

DAVOL IMPLANT PORTS W/ATTACH HI PERF GROSHONG CATH

K-Number: K913235 · 1991-10-31

ApplicantDavol, Inc.
Decision Date1991-10-31
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DAVOL IMPLANT PORTS W/ATTACH HI PERF GROSHONG CATH is the device name listed in this FDA 510(k) record. The listed applicant is Davol, Inc.. It received FDA 510(k) clearance on 1991-10-31 under 510(k) number K913235. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DAVOL IMPLANT PORTS W/ATTACH HI PERF GROSHONG CATH?

DAVOL IMPLANT PORTS W/ATTACH HI PERF GROSHONG CATH is a medical device that received FDA 510(k) clearance on 1991-10-31. The listed applicant is Davol, Inc.. The 510(k) number is K913235.

When did DAVOL IMPLANT PORTS W/ATTACH HI PERF GROSHONG CATH receive FDA 510(k) clearance?

DAVOL IMPLANT PORTS W/ATTACH HI PERF GROSHONG CATH received FDA 510(k) clearance on 1991-10-31, under 510(k) number K913235.

Who is the listed applicant for DAVOL IMPLANT PORTS W/ATTACH HI PERF GROSHONG CATH?

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

What is the FDA product code for DAVOL IMPLANT PORTS W/ATTACH HI PERF GROSHONG CATH?

The FDA product code for DAVOL IMPLANT PORTS W/ATTACH HI PERF GROSHONG CATH is FMF.

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Other records listing Davol, 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.

K251557Bard® Mesh; Bard® Mesh Pre-ShapedK250098Bard Soft Mesh; Bard Soft Mesh Pre-ShapedK031213AQUASENS FLUID MONITORING SYSTEMK030307DAVOL ARTHROVENT OUTFLOW TUBINGK003323COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205K003790DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005

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Related Devices (Code: FMF)

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.

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLCK252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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