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FDA 510(k)

ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE

K-Number: K862549 · 1986-07-15

ApplicantAmerican Bentley
Decision Date1986-07-15
Product CodeKRI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE is the device name listed in this FDA 510(k) record. The listed applicant is American Bentley. It received FDA 510(k) clearance on 1986-07-15 under 510(k) number K862549. 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 ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE?

ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE is a medical device that received FDA 510(k) clearance on 1986-07-15. The listed applicant is American Bentley. The 510(k) number is K862549.

When did ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE receive FDA 510(k) clearance?

ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE received FDA 510(k) clearance on 1986-07-15, under 510(k) number K862549.

Who is the listed applicant for ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE?

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 ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE?

The FDA product code for ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE is KRI.

Related Clinical Trials

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.

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Other records listing American Bentley 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.

K872896UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100K873923INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTERK870804CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100K872167CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500K872133OXYGENATOR MODEL NO. BENTLEY 5 PLUSK870911INDWELLING BLOOD CARBONDIOXIDE PARTIAL PRES. ANALY

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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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