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FDA 510(k)

THORA-KLEX CHEST DRAINAGE UNIT

K-Number: K905448 · 1991-03-27

ApplicantDavol, Inc.
Decision Date1991-03-27
Product CodeGCX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

THORA-KLEX CHEST DRAINAGE UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Davol, Inc.. It received FDA 510(k) clearance on 1991-03-27 under 510(k) number K905448. The device is classified under product code GCX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THORA-KLEX CHEST DRAINAGE UNIT?

THORA-KLEX CHEST DRAINAGE UNIT is a medical device that received FDA 510(k) clearance on 1991-03-27. The listed applicant is Davol, Inc.. The 510(k) number is K905448.

When did THORA-KLEX CHEST DRAINAGE UNIT receive FDA 510(k) clearance?

THORA-KLEX CHEST DRAINAGE UNIT received FDA 510(k) clearance on 1991-03-27, under 510(k) number K905448.

Who is the listed applicant for THORA-KLEX CHEST DRAINAGE UNIT?

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 THORA-KLEX CHEST DRAINAGE UNIT?

The FDA product code for THORA-KLEX CHEST DRAINAGE UNIT is GCX.

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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: GCX)

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.

K042454STRYKER CASSETTE PUMPStryker EndoscopyK992126CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEMCircon Corp.K972074SUCTION INSTRUMENTATIONWalter Lorenz Surgical, Inc.K971022CHASE SUCKERChase Medical, Inc.K964127MEDI-VAC FLEXI-CLEAR SUCTION HANDLEAllegiance Healthcare Corp.K964519CURITY THORACENTESIS TRAYKendall Healthcare Products Co. Div.Of Tyco Health

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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