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FDA 510(k)

VENOUS RESERVOIR-BMR-1500-HARD SHELL

K-Number: K842373 · 1984-12-27

ApplicantAmerican Bentley
Decision Date1984-12-27
Product CodeDTP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VENOUS RESERVOIR-BMR-1500-HARD SHELL is the device name listed in this FDA 510(k) record. The listed applicant is American Bentley. It received FDA 510(k) clearance on 1984-12-27 under 510(k) number K842373. 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 VENOUS RESERVOIR-BMR-1500-HARD SHELL?

VENOUS RESERVOIR-BMR-1500-HARD SHELL is a medical device that received FDA 510(k) clearance on 1984-12-27. The listed applicant is American Bentley. The 510(k) number is K842373.

When did VENOUS RESERVOIR-BMR-1500-HARD SHELL receive FDA 510(k) clearance?

VENOUS RESERVOIR-BMR-1500-HARD SHELL received FDA 510(k) clearance on 1984-12-27, under 510(k) number K842373.

Who is the listed applicant for VENOUS RESERVOIR-BMR-1500-HARD SHELL?

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

What is the FDA product code for VENOUS RESERVOIR-BMR-1500-HARD SHELL?

The FDA product code for VENOUS RESERVOIR-BMR-1500-HARD SHELL is DTP.

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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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