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FDA 510(k)

PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTER

K-Number: K884534 · 1989-01-24

ApplicantPall Biomedical Products Co.
Decision Date1989-01-24
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Pall Biomedical Products Co.. It received FDA 510(k) clearance on 1989-01-24 under 510(k) number K884534. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTER?

PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTER is a medical device that received FDA 510(k) clearance on 1989-01-24. The listed applicant is Pall Biomedical Products Co.. The 510(k) number is K884534.

When did PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTER receive FDA 510(k) clearance?

PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTER received FDA 510(k) clearance on 1989-01-24, under 510(k) number K884534.

Who is the listed applicant for PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTER?

The FDA 510(k) record lists Pall Biomedical Products Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTER?

The FDA product code for PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTER is JPA.

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Other records listing Pall Biomedical Products Co. 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.

K954331PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER)K960993PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST)K905794PALL 3N1 FILTERK902518LD-SIX ARTERIAL BLOOD FILTER FOR EXTRA. SERVICEK875095PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANEK875094ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE

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Related Devices (Code: JPA)

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.

K253658STA Satellite Max®Diagnostica Stago, Inc.K250965Automated Blood Coagulation Analyzer CN-Series (CN-6000)Sysmex America, Inc.K251024TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemoneticsK243858TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemonetics CorporationK232018Citrated: K, KH, RTH, FFHHaemonetics CorporationK233790ACL TOP 970 CLInstrumentation Laboratory

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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