Cleared Special

Tamarin Blue PTCA RX Dilatation Catheter

K210012 · Natec Medical , Ltd. · Cardiovascular
Jul 2021
Decision
186d
Days
Class 2
Risk

About This 510(k) Submission

K210012 is an FDA 510(k) clearance for the Tamarin Blue PTCA RX Dilatation Catheter, a Catheters, Transluminal Coronary Angioplasty, Percutaneous (Class II — Special Controls, product code LOX), submitted by Natec Medical , Ltd. (Reduit, MU). The FDA issued a Cleared decision on July 9, 2021, 186 days after receiving the submission on January 4, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5100.

Submission Details

510(k) Number K210012 FDA.gov
FDA Decision Cleared SESE
Date Received January 04, 2021
Decision Date July 09, 2021
Days to Decision 186 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code LOX — Catheters, Transluminal Coronary Angioplasty, Percutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5100
Definition A Ptca Catheter Is A Device That Operates On The Principle Of Hydraulic Pressurization Applied Through An Inflatable Balloon Attached To The Distal End.

Similar Devices — LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous

All 82
Sprinter Legend Rapid Exchange Balloon Dilatation Catheter
K251970 · Medtronic, Ireland · Jan 2026
Pantera Pro; Pantera LEO
K242969 · Biotronik, Inc. · Oct 2024
Sapphire NC ULTRA Coronary Dilatation Catheter
K233499 · OrbusNeich Medical (Shenzhen) Co., Ltd. · Aug 2024
Sapphire ULTRA Coronary Dilatation Catheter
K233505 · OrbusNeich Medical (Shenzhen) Co., Ltd. · Aug 2024
Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon catheter, 2.50 x 20mm (5882); Ringer perfusion balloon catheter, 2.50 x 30mm (5883); Ringer perfusion balloon catheter, 3.00 x 20mm (5884); Ringer perfusion balloon catheter, 3.00 x 30mm (5885); Ringer perfusion balloon catheter, 3.50 x 20mm (5886); Ringer perfusion balloon catheter, 3.50 x 30mm (5887); Ringer perfusion balloon catheter, 4.00 x 20mm (5888); Ringer perfusion balloon catheter, 4.00 x 30mm (58
K233729 · Vascular Solutions, LLC · May 2024
Firefighter? NC Pro PTCA Balloon Catheter
K223189 · Shanghai MicroPort Medical (Group) Co., Ltd. · Jul 2023