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FDA 510(k)

PRE-BYPASS FILTER

K-Number: K812539 · 1981-10-13

ApplicantGelman Sciences, Inc.
Decision Date1981-10-13
Product CodeKRJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PRE-BYPASS FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Gelman Sciences, Inc.. It received FDA 510(k) clearance on 1981-10-13 under 510(k) number K812539. 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?

PRE-BYPASS FILTER is a medical device that received FDA 510(k) clearance on 1981-10-13. The listed applicant is Gelman Sciences, Inc.. The 510(k) number is K812539.

When did PRE-BYPASS FILTER receive FDA 510(k) clearance?

PRE-BYPASS FILTER received FDA 510(k) clearance on 1981-10-13, under 510(k) number K812539.

Who is the listed applicant for PRE-BYPASS FILTER?

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

What is the FDA product code for PRE-BYPASS FILTER?

The FDA product code for PRE-BYPASS FILTER is KRJ.

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Other records listing Gelman Sciences, 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.

K946190DRUG DISPENSING SPIKEK943127PHARMASSURE LARGE VOLUME TRANSFER FILTERSK941589SYRINGE FILTER DEVICESK941020DRUG RECONSTITUTION FILTER DEVICEK942275VIAL VENT FILTERK941032UNKNOWN

View all 32 devices →

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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