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FDA 510(k)

VALVE, PRESSURE RELIEF, BLOOD OXYGENATOR

K-Number: K770681 · 1977-04-26

ApplicantScimed Life Systems, Inc.
Decision Date1977-04-26
Product CodeKRI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VALVE, PRESSURE RELIEF, BLOOD OXYGENATOR is the device name listed in this FDA 510(k) record. The listed applicant is Scimed Life Systems, Inc.. It received FDA 510(k) clearance on 1977-04-26 under 510(k) number K770681. 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 VALVE, PRESSURE RELIEF, BLOOD OXYGENATOR?

VALVE, PRESSURE RELIEF, BLOOD OXYGENATOR is a medical device that received FDA 510(k) clearance on 1977-04-26. The listed applicant is Scimed Life Systems, Inc.. The 510(k) number is K770681.

When did VALVE, PRESSURE RELIEF, BLOOD OXYGENATOR receive FDA 510(k) clearance?

VALVE, PRESSURE RELIEF, BLOOD OXYGENATOR received FDA 510(k) clearance on 1977-04-26, under 510(k) number K770681.

Who is the listed applicant for VALVE, PRESSURE RELIEF, BLOOD OXYGENATOR?

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

What is the FDA product code for VALVE, PRESSURE RELIEF, BLOOD OXYGENATOR?

The FDA product code for VALVE, PRESSURE RELIEF, BLOOD OXYGENATOR is KRI.

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Other records listing Scimed Life Systems, 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.

K974241SCIMED INFORMER PRESSURE WIRE SYSTEMK981788SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETERK980360SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRESK974559SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERSK974684SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETERK973945LUGE GUIDE WIRE

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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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