Product code ODY

Device name: Tunneled Catheter Remover
Medical specialty: General Hospital
Device class: 2
Regulation number: 880.5970
Review panel: HO
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Ineligible
Definition: 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 safely removed from the body.
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K122263	14.5-16.0 FRENCH CUFFED CATHETER REMOVAL DEVICE, SYMMETRY SURGICAL SINGEL USE	Symmetry Medical	2012-09-28
K063048	TRANS-CATHETER EXTRACTOR	Tran Pa-C, Inc.	2007-09-14

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00884450051337	Outake®	Merit Medical Systems, Inc.	2017-02-15
10884450051334	Outake®	Merit Medical Systems, Inc.	2017-02-15
00884450052587	Outake®	Merit Medical Systems, Inc.	2017-02-09
10884450052584	Outake®	Merit Medical Systems, Inc.	2017-02-09
00884450045497	Outake®	Merit Medical Systems, Inc.	2017-02-08
10884450045494	Outake®	Merit Medical Systems, Inc.	2017-02-08

Related 510(k) Records#