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FDA 510(k)

BUBBLE TRAP-FILTER CAT. NO B180F37

K-Number: K873316 · 1988-07-14

ApplicantAmerican Omni Medical, Inc.
Decision Date1988-07-14
Product CodeDTM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BUBBLE TRAP-FILTER CAT. NO B180F37 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 1988-07-14 under 510(k) number K873316. The device is classified under product code DTM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BUBBLE TRAP-FILTER CAT. NO B180F37?

BUBBLE TRAP-FILTER CAT. NO B180F37 is a medical device that received FDA 510(k) clearance on 1988-07-14. The listed applicant is American Omni Medical, Inc.. The 510(k) number is K873316.

When did BUBBLE TRAP-FILTER CAT. NO B180F37 receive FDA 510(k) clearance?

BUBBLE TRAP-FILTER CAT. NO B180F37 received FDA 510(k) clearance on 1988-07-14, under 510(k) number K873316.

Who is the listed applicant for BUBBLE TRAP-FILTER CAT. NO B180F37?

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 BUBBLE TRAP-FILTER CAT. NO B180F37?

The FDA product code for BUBBLE TRAP-FILTER CAT. NO B180F37 is DTM.

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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 & 700K875080AIR VENT LINE CAT. NO. AVL-36

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Related Devices (Code: DTM)

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.

K251744Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood FilterMedtronicK242953KIDS Arterial FiltersSorin Group Italia S.R.L.K242092MICRO Arterial FiltersSorin Group Italia S.R.L.K231362OCS Heart Leukocyte Depleting FilterTransMedics, Inc.K123351AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACEMedtronic Perfusion SystemsK122760AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACEMedtronic, 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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