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FDA 510(k)

SHILEY 3L CARDIOTOMY RESERVOIR

K-Number: K853503 · 1985-11-14

ApplicantShiley, Inc.
Decision Date1985-11-14
Product CodeDTP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SHILEY 3L CARDIOTOMY RESERVOIR is the device name listed in this FDA 510(k) record. The listed applicant is Shiley, Inc.. It received FDA 510(k) clearance on 1985-11-14 under 510(k) number K853503. 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 3L CARDIOTOMY RESERVOIR?

SHILEY 3L CARDIOTOMY RESERVOIR is a medical device that received FDA 510(k) clearance on 1985-11-14. The listed applicant is Shiley, Inc.. The 510(k) number is K853503.

When did SHILEY 3L CARDIOTOMY RESERVOIR receive FDA 510(k) clearance?

SHILEY 3L CARDIOTOMY RESERVOIR received FDA 510(k) clearance on 1985-11-14, under 510(k) number K853503.

Who is the listed applicant for SHILEY 3L CARDIOTOMY RESERVOIR?

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 3L CARDIOTOMY RESERVOIR?

The FDA product code for SHILEY 3L CARDIOTOMY RESERVOIR 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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