Angeion Corp.
United StatesFDA applicant, unverified
- Devices
- 7
What Angeion Corp. makes
Angeion Corp. manufactures medical devices primarily for endoscopic and procedural applications, including valve seals, adapters, and introducers for catheter-based procedures. Their portfolio includes specialized components like the Angioflator and Angioflator Digital for vascular access, as well as hemostasis valves and drainage sheaths for pericardial procedures. The company also produces Y-adapters with Thouy borst connectors for connecting tubing in medical setups.
The company’s devices are classified under FDA regulations as Class I and Class II, with most submissions requiring a 510(k) clearance. These products are listed in the FDA’s 510(k) registry, indicating their regulatory pathway in the United States. Angeion Corp. is headquartered in the US.
Catalogue
Angeion Endoscopic Valve Seal Ref K915719
Regimes: 510(k) Registry: 510(k)Y-Adapter W/Thouy Borst Ref K895580
Regimes: 510(k) Registry: 510(k)Angeflator(Tm) Ref K902377
Regimes: 510(k) Registry: 510(k)Angeion Igital Angeflator Ref K921757
Regimes: 510(k) Registry: 510(k)Angeion Hemostasis Valve Introducer Ref K894446
Regimes: 510(k) Registry: 510(k)Catheter Introducer Ref K871153
Regimes: 510(k) Registry: 510(k)Angestat(R) Pericardial Drainage Sheath Set Ref K925533
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Angeion Corp. have in the registry?
The registry currently lists 7 devices for Angeion Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Angeion Corp.'s devices?
Among its 7 most recently registered devices, Angeion Corp. has devices listed in FDA 510(k) (7 devices).
What risk classes do Angeion Corp.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Angeion Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Angeion Corp. in the registry?
The most recently registered devices listed for Angeion Corp. include ANGEION ENDOSCOPIC VALVE SEAL, Y-ADAPTER W/THOUY BORST, ANGEFLATOR(TM) and ANGEION IGITAL ANGEFLATOR.