510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K953118Substantially Equivalent

Caracell

Medtronic, Inc., Parker CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953118 is the FDA 510(k) clearance record for CARACELL, a class II device, cleared for Medtronic Vascular on under FDA product code CAC (Apparatus, Autotransfusion). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K953118.

Clearance record

Decision date
Received
(235 days to decision)
Product code
CAC Apparatus, Autotransfusion
Regulation
21 CFR 868.5830
Device class
Class II
Review panel
Anesthesiology
Applicant
Medtronic Vascular 18501 E Plz. Dr., Parker CO
510(k) summary
Statement
Third party review
No

Clearances, product code CAC

Trailing 12 months

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

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