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FDA 510(k)

EXTENDED SHELF LIFE FOR INTERSEPT* ARTERIAL 20/40

K-Number: K882137 · 1988-08-12

ApplicantMedtronic Blood Systems, Inc.
Decision Date1988-08-12
Product CodeDTM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EXTENDED SHELF LIFE FOR INTERSEPT* ARTERIAL 20/40 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Blood Systems, Inc.. It received FDA 510(k) clearance on 1988-08-12 under 510(k) number K882137. 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 EXTENDED SHELF LIFE FOR INTERSEPT* ARTERIAL 20/40?

EXTENDED SHELF LIFE FOR INTERSEPT* ARTERIAL 20/40 is a medical device that received FDA 510(k) clearance on 1988-08-12. The listed applicant is Medtronic Blood Systems, Inc.. The 510(k) number is K882137.

When did EXTENDED SHELF LIFE FOR INTERSEPT* ARTERIAL 20/40 receive FDA 510(k) clearance?

EXTENDED SHELF LIFE FOR INTERSEPT* ARTERIAL 20/40 received FDA 510(k) clearance on 1988-08-12, under 510(k) number K882137.

Who is the listed applicant for EXTENDED SHELF LIFE FOR INTERSEPT* ARTERIAL 20/40?

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

What is the FDA product code for EXTENDED SHELF LIFE FOR INTERSEPT* ARTERIAL 20/40?

The FDA product code for EXTENDED SHELF LIFE FOR INTERSEPT* ARTERIAL 20/40 is DTM.

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Other records listing Medtronic Blood Systems, Inc. as applicant

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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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