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FDA 510(k)

FILTER, INFUSION BLOOD (1 PFF-100)

K-Number: K760165 · 1976-08-06

ApplicantBentley Laboratories, Inc.
Decision Date1976-08-06
Product CodeCAK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FILTER, INFUSION BLOOD (1 PFF-100) 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 1976-08-06 under 510(k) number K760165. The device is classified under product code CAK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FILTER, INFUSION BLOOD (1 PFF-100)?

FILTER, INFUSION BLOOD (1 PFF-100) is a medical device that received FDA 510(k) clearance on 1976-08-06. The listed applicant is Bentley Laboratories, Inc.. The 510(k) number is K760165.

When did FILTER, INFUSION BLOOD (1 PFF-100) receive FDA 510(k) clearance?

FILTER, INFUSION BLOOD (1 PFF-100) received FDA 510(k) clearance on 1976-08-06, under 510(k) number K760165.

Who is the listed applicant for FILTER, INFUSION BLOOD (1 PFF-100)?

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 FILTER, INFUSION BLOOD (1 PFF-100)?

The FDA product code for FILTER, INFUSION BLOOD (1 PFF-100) is CAK.

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Other records listing Bentley Laboratories, 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.

K931967HE-30 GOLDK913956BLOOD CARDIOPLEGIA HEAT EXCHANGER, MODEL #HE-30K913692VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM)K903641QUICK PRIME HEMOCONCEN. NO. HQ-7000 AND CBP-7000QK894826UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLFK874867CATR(TM)-H CARDIOTOMY HOLDER

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Related Devices (Code: CAK)

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.

K061103HAEMONETICS 40U RBC FILTER BAGHaemonetics Corp.K022477SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SETSummit Medical , Ltd.K000719NEOCARE 20 MICRON BLOOD FILTERWhatman, Inc.K990310CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER)Charter Medical, Ltd.K982822FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72Baxter Healthcare CorpK972159FENWAL 40 MICRON TRANSFUSION FILTERBaxter Healthcare Corp

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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