510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K974146Substantially Equivalent

Paracentesis Catheter Device

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

K974146 is the FDA 510(k) clearance record for PARACENTESIS CATHETER DEVICE, a class I device, cleared for Allegiance Healthcare Corp. on under FDA product code GCB (Needle, Catheter). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K974146.

Clearance record

Decision date
Received
(86 days to decision)
Product code
GCB Needle, Catheter
Regulation
21 CFR 878.4200
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Allegiance Healthcare Corp. 1435 Lake Cook Rd., Deerfield IL
510(k) summary
Summary
Third party review
No

Clearances, product code GCB

Trailing 12 months

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

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