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FDA 510(k)

PRE-BYPASS FILTER #EC-PBF SERIES

K-Number: K832594 · 1983-09-20

ApplicantGish Biomedical, Inc.
Decision Date1983-09-20
Product CodeKRJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PRE-BYPASS FILTER #EC-PBF SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Gish Biomedical, Inc.. It received FDA 510(k) clearance on 1983-09-20 under 510(k) number K832594. 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 PRE-BYPASS FILTER #EC-PBF SERIES?

PRE-BYPASS FILTER #EC-PBF SERIES is a medical device that received FDA 510(k) clearance on 1983-09-20. The listed applicant is Gish Biomedical, Inc.. The 510(k) number is K832594.

When did PRE-BYPASS FILTER #EC-PBF SERIES receive FDA 510(k) clearance?

PRE-BYPASS FILTER #EC-PBF SERIES received FDA 510(k) clearance on 1983-09-20, under 510(k) number K832594.

Who is the listed applicant for PRE-BYPASS FILTER #EC-PBF SERIES?

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

What is the FDA product code for PRE-BYPASS FILTER #EC-PBF SERIES?

The FDA product code for PRE-BYPASS FILTER #EC-PBF SERIES is KRJ.

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Other records listing Gish Biomedical, 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.

K090450MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LTK090449MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LTK091062MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730K083131MEDOS HILITE RESERVOIR, MODEL: 4030K082403MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LTK082082GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING

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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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