TRANS-CATHETER EXTRACTOR— 510(k) K063048

Substantially Equivalent

Tran Pa-C, Inc.

FDA 510(k) clearance K063048 for TRANS-CATHETER EXTRACTOR, Substantially Equivalent on 2007-09-14. Applicant: Tran Pa-C, Inc.. Device class: 2.

Clearance details

Applicant: Tran Pa-C, Inc.
Product code: Code ODY
Device class: Class 2
Regulation: 21 CFR 880.5970
Advisory panel: General Hospital
Date received: 2006-10-04
Decision date: 2007-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orlando, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ODY

K122263 — 14.5-16.0 FRENCH CUFFED CATHETER REMOVAL DEVICE, SYMMETRY SURGICAL SINGEL USE2012-09-28

Recalls naming K063048

K-number listed on FDA's recall record

Z-2559-2024 — Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Outake, REF CET200 and CET300, The Catheter Extractor is a catheter accessory device intended for minimally invasive removal of tunneled long term catheters. The Catheter Extractor is indicated for use with tunneled, double lumen hemodialysis catheters with cuff sizes ranging from 10.8 French to 14.5 French.Class II·Ongoing·Merit Medical Systems, Inc.·20240611

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K063048.

Data sourced from openFDA. This site is unofficial and independent of the FDA.