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FDA 510(k)

VENTROFIL TENSION RELIEF SUTURE SET

K-Number: K904435 · 1991-08-29

ApplicantAesculap, Inc.
Decision Date1991-08-29
Product CodeKGS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VENTROFIL TENSION RELIEF SUTURE SET is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 1991-08-29 under 510(k) number K904435. The device is classified under product code KGS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENTROFIL TENSION RELIEF SUTURE SET?

VENTROFIL TENSION RELIEF SUTURE SET is a medical device that received FDA 510(k) clearance on 1991-08-29. The listed applicant is Aesculap, Inc.. The 510(k) number is K904435.

When did VENTROFIL TENSION RELIEF SUTURE SET receive FDA 510(k) clearance?

VENTROFIL TENSION RELIEF SUTURE SET received FDA 510(k) clearance on 1991-08-29, under 510(k) number K904435.

Who is the listed applicant for VENTROFIL TENSION RELIEF SUTURE SET?

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

What is the FDA product code for VENTROFIL TENSION RELIEF SUTURE SET?

The FDA product code for VENTROFIL TENSION RELIEF SUTURE SET is KGS.

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Other records listing Aesculap, Inc. as applicant

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K242762Aesculap Aicon® Series Container SystemK242003XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetK223596SQ.line KERRISONK214041Aesculap AICON ContainerK211572Aesculap Slim Clip ApplierK203739ELAN 4 Electro Motor System

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Related Devices (Code: KGS)

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.

K030031SOFT TISSUE ANCHORING WASHERSAccu-Speed, IncorporatedK020480RBMSmith & Nephew, Inc.K964935SUTURE LOCKSmith & Nephew Endoscopy, Inc.K941740ACUFEX ROTATOR CUFF FIXATION BUTTONAcufex Microsurgical, Inc.K930675MITEK CONE WASHERMitek Surgical Products, Inc.K911225TRAY DOUGHThe Hygenic Corp.

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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