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FDA 510(k)

SHILEY CARDIOTOMY RESERVOIR W/FILTER

K-Number: K801375 · 1980-07-14

ApplicantShiley, Inc.
Decision Date1980-07-14
Product CodeDTP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SHILEY CARDIOTOMY RESERVOIR W/FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Shiley, Inc.. It received FDA 510(k) clearance on 1980-07-14 under 510(k) number K801375. The device is classified under product code DTP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHILEY CARDIOTOMY RESERVOIR W/FILTER?

SHILEY CARDIOTOMY RESERVOIR W/FILTER is a medical device that received FDA 510(k) clearance on 1980-07-14. The listed applicant is Shiley, Inc.. The 510(k) number is K801375.

When did SHILEY CARDIOTOMY RESERVOIR W/FILTER receive FDA 510(k) clearance?

SHILEY CARDIOTOMY RESERVOIR W/FILTER received FDA 510(k) clearance on 1980-07-14, under 510(k) number K801375.

Who is the listed applicant for SHILEY CARDIOTOMY RESERVOIR W/FILTER?

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

What is the FDA product code for SHILEY CARDIOTOMY RESERVOIR W/FILTER?

The FDA product code for SHILEY CARDIOTOMY RESERVOIR W/FILTER is DTP.

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Other records listing Shiley, 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.

K920594SHILEY PERFUSION TUBING SETSK910991SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEMK911876SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200K910923BCD ADVANCEDK901548BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GASK903435SHILEY SPECIALIZED TRACHEOSTOMY TUBE

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Related Devices (Code: DTP)

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.

K101186AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAGMedtronic Perfusion SystemsK082412VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODEL BE-VBT 160, BEQ-VBT 160Mapquet Cardiopulmonary AGK004046COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIRCobe Cardiovascular, Inc.K002591COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIRCobe Cardiovascular, Inc.K990514MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VRC.R. Bard, Inc.K984322DIDECO D920, LILLIPUT 1 TWIN RESERVOIRDideco S.P.A.

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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