510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K882380Substantially Equivalent

Scimed Model Sm-C/vr Cardiotomy/venous Reservoir

Scimed Life Systems, Inc., Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882380 is the FDA 510(k) clearance record for SCIMED MODEL SM-C/VR CARDIOTOMY/VENOUS RESERVOIR, a class II device, cleared for Scimed Life Systems, Inc. on under FDA product code DTN (Reservoir, Blood, Cardiopulmonary Bypass). FDA records list 109 510(k) clearances for Scimed Life Systems, Inc., from to . As of , FDA records show no recalls naming K882380.

Clearance record

Decision date
Received
(119 days to decision)
Product code
DTN Reservoir, Blood, Cardiopulmonary Bypass
Regulation
21 CFR 870.4400
Device class
Class II
Review panel
Cardiovascular
Applicant
Scimed Life Systems, Inc. 13000 County Rd. 6, Minneapolis MN
Third party review
No

Clearances, product code DTN

Trailing 12 months
1 clearance under product code DTN in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DTN, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260