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FDA 510(k)

PRE-BYPASS FILTER

K-Number: K810395 · 1981-03-05

ApplicantTexas Medical Products, Inc.
Decision Date1981-03-05
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 Texas Medical Products, Inc.. It received FDA 510(k) clearance on 1981-03-05 under 510(k) number K810395. 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 1981-03-05. The listed applicant is Texas Medical Products, Inc.. The 510(k) number is K810395.

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

PRE-BYPASS FILTER received FDA 510(k) clearance on 1981-03-05, under 510(k) number K810395.

Who is the listed applicant for PRE-BYPASS FILTER?

The FDA 510(k) record lists Texas Medical Products, 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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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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