510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K990103Substantially Equivalent

Monolyth C 600 and 1200 Hollow Fiber Membrane Lung with Integrated Softshell Venous Reservoir , Cvr 600 and 1200 Softshe

Sorin Biomedical, Inc., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K990103 is the FDA 510(k) clearance record for MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL VENOUS RESERVOIR , CVR 600 AND 1200 SOFTSHE, a class II device, cleared for Sorin Biomedical, Inc. on under FDA product code DTZ (Oxygenator, Cardiopulmonary Bypass). FDA records list 15 510(k) clearances for Sorin Biomedical, Inc., from to . As of , FDA records show no recalls naming K990103.

Clearance record

Decision date
Received
(297 days to decision)
Product code
DTZ Oxygenator, Cardiopulmonary Bypass
Regulation
21 CFR 870.4350
Device class
Class II
Review panel
Cardiovascular
Applicant
Sorin Biomedical, Inc. 17600 Gillette Ave., Irvine CA
510(k) summary
Summary
Third party review
No

Clearances, product code DTZ

Trailing 12 months
5 clearances under product code DTZ in the twelve months to October 2026, March 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code DTZ, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20262
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260