Ablacon Inc.
United StatesFDA applicant, unverified
Ablacon Inc. is a medical device manufacturer, with 8 devices listed in FDA GUDID and FDA 510(k) (FDA Class II) as of 13 Nov 2026.
- Devices
- 8
Registry facts
- Registries
- FDA GUDID 5
- FDA 510(k) 3
- Device classes
- FDA Class II 8
- Identifiers
- DUNS 106083214
What Ablacon Inc. makes
Ablacon Inc. manufactures single-use cardiac mapping catheters designed for percutaneous procedures, reusable electrical connection cables for medical device interfacing, and computer systems with specialized software for cardiac mapping. Their products include catheter extension cables and integrated mapping systems for electrophysiological studies and ablation procedures.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) and UDI registries.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
Ablacath™ Mapping Catheter Ref K223666
Regimes: 510(k) Registry: 510(k)Ablamap® System Ref K230008
Regimes: 510(k) Registry: 510(k)Ablamap Software Ref K203084
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 106083214
- contact@ablacon.com
- Phone
- 303-995-5620
Frequently asked questions
How many devices does Ablacon Inc. have in the registry?
The registry currently lists 8 devices for Ablacon Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ablacon Inc.'s devices?
Among its 8 most recently registered devices, Ablacon Inc. has devices listed in FDA 510(k) (3 devices) and FDA GUDID (5 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Ablacon Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Ablacon Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ablacon Inc. in the registry?
The most recently registered devices listed for Ablacon Inc. include Ablacon™ Mapping Catheter AB-0003-60, Ablacon™ Mapping Catheter AB-0003-50, Ablacath System Interconnect Cable AB-0005 and Ablamap® System AB-0007.