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FDA 510(k)

CARDIOTOMY RESERVOIR CR-2000

K-Number: K790116 · 1979-02-08

ApplicantDelta Medical Industries
Decision Date1979-02-08
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOTOMY RESERVOIR CR-2000 is the device name listed in this FDA 510(k) record. The listed applicant is Delta Medical Industries. It received FDA 510(k) clearance on 1979-02-08 under 510(k) number K790116. The device is classified under product code DTB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOTOMY RESERVOIR CR-2000?

CARDIOTOMY RESERVOIR CR-2000 is a medical device that received FDA 510(k) clearance on 1979-02-08. The listed applicant is Delta Medical Industries. The 510(k) number is K790116.

When did CARDIOTOMY RESERVOIR CR-2000 receive FDA 510(k) clearance?

CARDIOTOMY RESERVOIR CR-2000 received FDA 510(k) clearance on 1979-02-08, under 510(k) number K790116.

Who is the listed applicant for CARDIOTOMY RESERVOIR CR-2000?

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

What is the FDA product code for CARDIOTOMY RESERVOIR CR-2000?

The FDA product code for CARDIOTOMY RESERVOIR CR-2000 is DTB.

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Related Devices (Code: DTB)

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K061212BIOTRONIK ENDOCARDIAL PACING LEADSBiotronik, Inc.K041809PERMANENT PACING LEAD, MODEL PY2Oscor, Inc.K040569PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJUOscor, Inc.K031274MODEL 5071 MYOCARDIAL PACING LEADMedtronic VascularK031210MODEL 4951M MYOCARDIAL UNIPOLAR LEADMetronic, Inc.K023205ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BPBiotronik, Inc.

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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