510(k) K101111 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
HALO ABLATION CATHETER MODEL 90-9100, HALO90 ULTRA ABLATION CATHETER MODEL 90-9200
| Applicant | Barrx Medical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jun 18, 2010 |
| Received | Apr 21, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K101111
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 6, 2011 | Barrx Medical, Inc. HALO Ultra Ablation Catheter:
Rx only; for use only with the Halo Flex Energy generator and accessories;
Manufactured in the USA at BRRX Medical, 540 Oakmead Parkway, Sunnyvale, CA 94085.
Product Usa Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.