Barrx Medical, Incorporated
Washington, DC, US
Barrx Medical, Incorporated appears in FDA device records in Washington, DC. FDA records list 13 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Barrx Medical, Incorporated between 2005 and 2010. The busiest year on record is 2006, with 4. The most recent is 2010, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2006 | 4 |
| 2007 | 1 |
| 2008 | 2 |
| 2009 | 3 |
| 2010 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K093855 | HALO 360 & SIZING BALLOON, MODEL 3441C | GEI | Substantially Equivalent | |
| K093008 | HALO ABLATION CATHETER, MODEL 90-9100 | GEI | Substantially Equivalent | |
| K092487 | HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230A | GEI | Substantially Equivalent | |
| K083737 | HALO ABLATION CATHETER | GEI | Substantially Equivalent | |
| K083711 | MODIFICATION TO: HALO COAGULATION CATHETER, MODELS 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, 32041-34 | GEI | Substantially Equivalent | |
| K082202 | HALO360 ENERGY GENERATOR, MODELS 1100C-115B AND 1100C-230B | GEI | Substantially Equivalent | |
| K080557 | BARRX MODELS HALO360 AND HALO360+ COAGULATION CATHETERS | GEI | Substantially Equivalent | |
| K071543 | HALO360' COAGULATION CATHETER | GEI | Substantially Equivalent | |
| K062441 | BARRX HALO COAGULATION SYSTEM; GENERATOR, MODEL 90-9000; OUTPUT CABLE, MODEL 90-9010; FOOTSWITCH, MODEL 90-9020 | GEI | Substantially Equivalent | |
| K062723 | HALO90 COAGULATION CATHETER | GEI | Substantially Equivalent | |
| K062225 | HALO COAGULATION CATHETER | GEI | Substantially Equivalent | |
| K060169 | BARRX HALO COAGULATION SYSTEM, BARRX HALO COAGULATION GENERATOR, BARRX COAGULATION CATHETER, MODELS 2200-115A, 1520F | GEI | Substantially Equivalent | |
| K051168 | BARRX HALO 360 SYSTEM, MODEL 1100C-115A | GEI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain