Pediatric Arterial Blood Filter

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K810068 ↗

FDA Product Code

DTM

Device Class

Class II

Regulation

21 CFR Part 870.4260

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• What is the Pediatric Arterial Blood Filter used for?

  The Pediatric Arterial Blood Filter is used in cardiopulmonary bypass procedures to filter blood in the arterial line, removing particulate matter and microemboli to help protect the patient during cardiac surgery.

• How is the Pediatric Arterial Blood Filter supplied and is it sterile?

  The device is supplied sterile for single-use only, as indicated by its FDA 510(k) clearance and classification as a blood filter for cardiopulmonary bypass; reuse is not permitted due to infection and integrity risks.

• What regulatory pathway was used for the Pediatric Arterial Blood Filter?

  The device received FDA 510(k) clearance (K810068) on January 22, 1981, as substantially equivalent to a legally marketed predicate device, following the traditional 510(k) submission pathway.

• What is the product code and device classification for the Pediatric Arterial Blood Filter?

  The device is assigned product code DTM and classified as a Class II medical device under FDA regulation 870.4260 for Filter, Blood, Cardiopulmonary Bypass, Arterial Line.