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FDA 510(k)

CARDIOPULMONARY BYPASS ACCESSORY EQUIP.

K-Number: K811348 · 1981-05-29

ApplicantBentley Laboratories, Inc.
Decision Date1981-05-29
Product CodeKRI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOPULMONARY BYPASS ACCESSORY EQUIP. is the device name listed in this FDA 510(k) record. The listed applicant is Bentley Laboratories, Inc.. It received FDA 510(k) clearance on 1981-05-29 under 510(k) number K811348. The device is classified under product code KRI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOPULMONARY BYPASS ACCESSORY EQUIP.?

CARDIOPULMONARY BYPASS ACCESSORY EQUIP. is a medical device that received FDA 510(k) clearance on 1981-05-29. The listed applicant is Bentley Laboratories, Inc.. The 510(k) number is K811348.

When did CARDIOPULMONARY BYPASS ACCESSORY EQUIP. receive FDA 510(k) clearance?

CARDIOPULMONARY BYPASS ACCESSORY EQUIP. received FDA 510(k) clearance on 1981-05-29, under 510(k) number K811348.

Who is the listed applicant for CARDIOPULMONARY BYPASS ACCESSORY EQUIP.?

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

What is the FDA product code for CARDIOPULMONARY BYPASS ACCESSORY EQUIP.?

The FDA product code for CARDIOPULMONARY BYPASS ACCESSORY EQUIP. is KRI.

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Other records listing Bentley Laboratories, Inc. as applicant

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Related Devices (Code: KRI)

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.

K0203653TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE3t Medical Systems, LLCK992635INTERFACE MODULE IDDDStoeckert InstrumenteK990512STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTSStoeckert InstrumenteK934782AMMEX TUBING ORGANIZERAmmex Cardiopulmonary Corp.K926233CARDIO2 CYCLEErgometrix, Inc.K922404TUBE GRIPGeorgia Medical Products, 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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