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FDA 510(k)

PREBYPASS FILTER

K-Number: K871350 · 1987-06-08

ApplicantAmerican Omni Medical, Inc.
Decision Date1987-06-08
Product CodeKRJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PREBYPASS FILTER is the device name listed in this FDA 510(k) record. The listed applicant is American Omni Medical, Inc.. It received FDA 510(k) clearance on 1987-06-08 under 510(k) number K871350. 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 PREBYPASS FILTER?

PREBYPASS FILTER is a medical device that received FDA 510(k) clearance on 1987-06-08. The listed applicant is American Omni Medical, Inc.. The 510(k) number is K871350.

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

PREBYPASS FILTER received FDA 510(k) clearance on 1987-06-08, under 510(k) number K871350.

Who is the listed applicant for PREBYPASS FILTER?

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

What is the FDA product code for PREBYPASS FILTER?

The FDA product code for PREBYPASS FILTER is KRJ.

Related Clinical Trials

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.

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Other records listing American Omni Medical, 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.

K922781FLOW CONROL VALVEK922356FLOW CONTROL VALVE, CAT. NO. ACV-38K900672PREBYPASS FILTER, CAT. NO. FPB-5K884893CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25K884640CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700K873316BUBBLE TRAP-FILTER CAT. NO B180F37

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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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