510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K063048Substantially Equivalent

Trans-Catheter Extractor

Tran Pa-C, Inc., Orlando FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063048 is the FDA 510(k) clearance record for TRANS-CATHETER EXTRACTOR, a class II device, cleared for Tran Pa-C, Inc. on under FDA product code ODY (Tunneled Catheter Remover). FDA's definition for product code ODY reads: "To assist in the removal of tunneled long term catheter cuffs using a minimal invasive technique by seperating the tissue ingrowth cuff from the surrounding tissue. Following seperation of the cuff from the tissue, the catheter can be...". FDA records list one 510(k) clearance for Tran Pa-C, Inc. As of , FDA records show one recall naming K063048.

Clearance record

Decision date
Received
(345 days to decision)
Product code
ODY Tunneled Catheter Remover
Regulation
21 CFR 880.5970
Device class
Class II
Review panel
General Hospital
Applicant
Tran Pa-C, Inc. 3348 Herringridge Dr., Orlando FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ODY

Trailing 12 months

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

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