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FDA 510(k)

AIR VENT LINE CAT. NO. AVL-36

K-Number: K875080 · 1988-02-29

ApplicantAmerican Omni Medical, Inc.
Decision Date1988-02-29
Product CodeDTM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AIR VENT LINE CAT. NO. AVL-36 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 1988-02-29 under 510(k) number K875080. 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 AIR VENT LINE CAT. NO. AVL-36?

AIR VENT LINE CAT. NO. AVL-36 is a medical device that received FDA 510(k) clearance on 1988-02-29. The listed applicant is American Omni Medical, Inc.. The 510(k) number is K875080.

When did AIR VENT LINE CAT. NO. AVL-36 receive FDA 510(k) clearance?

AIR VENT LINE CAT. NO. AVL-36 received FDA 510(k) clearance on 1988-02-29, under 510(k) number K875080.

Who is the listed applicant for AIR VENT LINE CAT. NO. AVL-36?

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 AIR VENT LINE CAT. NO. AVL-36?

The FDA product code for AIR VENT LINE CAT. NO. AVL-36 is DTM.

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.

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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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