510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K140197Substantially Equivalent

Pleur-Evac Plus Continuous Reinfusion and Autotransfusion System

Teleflexmedical, Inc., Research Triangle Park NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K140197 is the FDA 510(k) clearance record for PLEUR-EVAC PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM, a class II device, cleared for Teleflexmedical, Inc. on under FDA product code CAC (Apparatus, Autotransfusion). FDA records list 64 510(k) clearances for Teleflexmedical, Inc., from to . As of , FDA records show no recalls naming K140197.

Clearance record

Decision date
Received
(267 days to decision)
Product code
CAC Apparatus, Autotransfusion
Regulation
21 CFR 868.5830
Device class
Class II
Review panel
Anesthesiology
Applicant
Teleflexmedical, Inc. 2917 Weck Dr., Research Triangle Park NC
510(k) summary
Summary PDF
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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CAC, 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