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FDA 510(k)

DACRON PLEDGET SUTURE BUTTRESS

K-Number: K812254 · 1981-08-31

ApplicantETHICON, Inc.
Decision Date1981-08-31
Product CodeDXZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DACRON PLEDGET SUTURE BUTTRESS is the device name listed in this FDA 510(k) record. The listed applicant is ETHICON, Inc.. It received FDA 510(k) clearance on 1981-08-31 under 510(k) number K812254. The device is classified under product code DXZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DACRON PLEDGET SUTURE BUTTRESS?

DACRON PLEDGET SUTURE BUTTRESS is a medical device that received FDA 510(k) clearance on 1981-08-31. The listed applicant is ETHICON, Inc.. The 510(k) number is K812254.

When did DACRON PLEDGET SUTURE BUTTRESS receive FDA 510(k) clearance?

DACRON PLEDGET SUTURE BUTTRESS received FDA 510(k) clearance on 1981-08-31, under 510(k) number K812254.

Who is the listed applicant for DACRON PLEDGET SUTURE BUTTRESS?

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

What is the FDA product code for DACRON PLEDGET SUTURE BUTTRESS?

The FDA product code for DACRON PLEDGET SUTURE BUTTRESS is DXZ.

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Other records listing ETHICON, Inc. as applicant

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Related Devices (Code: DXZ)

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.

K240775PeriBeam® Pericardial MembraneTamabioK200955Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid PatchVascutek, Ltd.K162506PhotoFix Decellularized Bovine PericardiumCryolife, Inc.K162579VascuCelAdmedus Regen Pty, Ltd.K152127CorMatrix TykeCormatrix Cardiovascular, Inc.K122306SYNOVIS COLLAGEN MATRIX (TBD)Synovis Surgical Innovations

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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