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FDA 510(k)

ULTIPORE PREBYPASS PLUS FILTER

K-Number: K831286 · 1983-06-08

ApplicantPall Biomedical Products Co.
Decision Date1983-06-08
Product CodeKRJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ULTIPORE PREBYPASS PLUS 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 1983-06-08 under 510(k) number K831286. The device is classified under product code KRJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTIPORE PREBYPASS PLUS FILTER?

ULTIPORE PREBYPASS PLUS FILTER is a medical device that received FDA 510(k) clearance on 1983-06-08. The listed applicant is Pall Biomedical Products Co.. The 510(k) number is K831286.

When did ULTIPORE PREBYPASS PLUS FILTER receive FDA 510(k) clearance?

ULTIPORE PREBYPASS PLUS FILTER received FDA 510(k) clearance on 1983-06-08, under 510(k) number K831286.

Who is the listed applicant for ULTIPORE PREBYPASS PLUS 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 ULTIPORE PREBYPASS PLUS FILTER?

The FDA product code for ULTIPORE PREBYPASS PLUS FILTER is KRJ.

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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. SERVICEK884534PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTERK875095PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANE

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Related Devices (Code: KRJ)

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.

K990276POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTERPorous Media Corp.K982385POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTERPorous Media Corp.K940126AVECOR PRE-BYPASS FILTERAvecor Cardiovascular, Inc.K900672PREBYPASS FILTER, CAT. NO. FPB-5American Omni Medical, Inc.K885154INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEMMedtronic Blood Systems, Inc.K884390INTERSEPT* CRYSTALLOID CARDIOPLEGIA FILTERMedtronic Blood Systems, 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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