Data / Medical devices / United States / Teleflex LLC
Teleflex LLC: FDA-registered device maker in Brooklyn Park, MN, United States, 8 510(k) clearances
Teleflex LLC is registered with the FDA (registration 3030236028) in Brooklyn Park, MN, United States. It lists 3 device types. The FDA files 8 510(k) clearances under its listings, the newest dated April 30, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030236028
- Address
- 9491 Winnetka Avenue, Brooklyn Park, MN, United States, 55445
- Owner or operator
- Vascular Solutions LLC (9029941)
- Roles
- Manufacturer
- First device listed
- November 4, 2013
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Percutaneous | DQY | 2 | Manufacturer | accessdata.fda.gov |
| Catheters, Transluminal Coronary Angioplasty, Percutaneous | LOX | 2 | Manufacturer | accessdata.fda.gov |
| Introducer, Catheter | DYB | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 30, 2021 | K210647 | SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter | DQY | Substantially Equivalent | Vascular Solutions, LLC | accessdata.fda.gov |
| June 29, 2020 | K193119 | Twin-Pass Dual Access Catheter | DQY | Substantially Equivalent | Vascular Solutions, LLC | accessdata.fda.gov |
| August 9, 2019 | K191560 | Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter | DQY | Substantially Equivalent | Vascular Solutions, LLC | accessdata.fda.gov |
| May 9, 2018 | K180913 | VSI Micro-Introducer Kit | DYB | Substantially Equivalent | Vascular Solutions, Inc. | accessdata.fda.gov |
| October 20, 2017 | K172090 | GuideLiner V3 Catheter | DQY | Substantially Equivalent | Vascular Solutions, Inc. | accessdata.fda.gov |
| February 1, 2017 | K162467 | Twin-Pass Torque | DQY | Substantially Equivalent | Vascular Solutions, Inc. | accessdata.fda.gov |
| June 23, 2016 | K153682 | Chocolate XD PTCA Balloon Catheter | LOX | Substantially Equivalent | Trireme Medical, LLC | accessdata.fda.gov |
| February 9, 2005 | K043525 | CATHETER INTRODUCER | DYB | Substantially Equivalent | Galt Medical Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Introducer, Catheter
- All makers of Catheter, Percutaneous
- All makers of Catheters, Transluminal Coronary Angioplasty, Percutaneous
Updated April 30, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.