510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K090006Substantially Equivalent

Lifebridge B2t, Model 7001

Lifebridge Medizintechnik AG, Bryn Mawr PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K090006 is the FDA 510(k) clearance record for LIFEBRIDGE B2T, MODEL 7001, a class II device, cleared for Lifebridge Medizintechnik AG on under FDA product code DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass). FDA records list 3 510(k) clearances for Lifebridge Medizintechnik AG, from to . As of , FDA records show no recalls naming K090006.

Clearance record

Decision date
Received
(286 days to decision)
Product code
DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Regulation
21 CFR 870.4220
Device class
Class II
Review panel
Cardiovascular
Applicant
Lifebridge Medizintechnik AG 1282 Round Hill Rd., Bryn Mawr PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DTQ

Trailing 12 months

FDA records hold no clearances under product code DTQ in the trailing twelve months.

FDA records show no clearances under product code DTQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DTQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260