FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HALO ABLATION CATHETER
K Number: K083737
·
Decision Feb 10, 2009
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
13
Review Days
56
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Basic Information
- Device Name
- HALO ABLATION CATHETER
- K Number
- K083737
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Barrx Medical, Incorporated
- Date Received
- December 16, 2008
- Decision Date
- February 10, 2009
- Product Code
- GEI
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Barrx Medical, Incorporated
| K Number | Device Name | ||
|---|---|---|---|
| K093855 | HALO 360 & SIZING BALLOON, MODEL 3441C | Jan 15, 2010 | Substantially Equivalent |
| K093008 | HALO ABLATION CATHETER, MODEL 90-9100 | Jan 8, 2010 | Substantially Equivalent |
| K092487 | HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230A | Nov 10, 2009 | Substantially Equivalent |
| K083711 | MODIFICATION TO: HALO COAGULATION CATHETER, MODELS 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, 32041-34 | Feb 2, 2009 | Substantially Equivalent |
| K082202 | HALO360 ENERGY GENERATOR, MODELS 1100C-115B AND 1100C-230B | Oct 8, 2008 | Substantially Equivalent |
| K080557 | BARRX MODELS HALO360 AND HALO360+ COAGULATION CATHETERS | Apr 2, 2008 | Substantially Equivalent |
| K071543 | HALO360' COAGULATION CATHETER | Jun 29, 2007 | Substantially Equivalent |
| K062441 | BARRX HALO COAGULATION SYSTEM; GENERATOR, MODEL 90-9000; OUTPUT CABLE, MODEL 90-9010; FOOTSWITCH, MODEL 90-9020 | Nov 14, 2006 | Substantially Equivalent |
| K062723 | HALO90 COAGULATION CATHETER | Nov 9, 2006 | Substantially Equivalent |
| K062225 | HALO COAGULATION CATHETER | Aug 28, 2006 | Substantially Equivalent |