510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K820954Substantially Equivalent

Scimed Model Sc 3000

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

K820954 is the FDA 510(k) clearance record for SCIMED MODEL SC 3000, a class II device, cleared for Scimed Life Systems, Inc. on under FDA product code DTP (Defoamer, Cardiopulmonary Bypass). FDA records list 109 510(k) clearances for Scimed Life Systems, Inc., from to . As of , FDA records show no recalls naming K820954.

Clearance record

Decision date
Received
(48 days to decision)
Product code
DTP Defoamer, Cardiopulmonary Bypass
Regulation
21 CFR 870.4230
Device class
Class II
Review panel
Cardiovascular
Applicant
Scimed Life Systems, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DTP

Trailing 12 months

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

FDA records show no clearances under product code DTP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DTP, 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