FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VECTOR PTA BALLOON DILATATION CATHETER
K Number: K131329
·
Decision Jun 6, 2013
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
402
Applicant Total
7
Review Days
29
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Basic Information
- Device Name
- VECTOR PTA BALLOON DILATATION CATHETER
- K Number
- K131329
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- R4 Vascular, Inc.
- Date Received
- May 8, 2013
- Decision Date
- June 6, 2013
- Product Code
- LIT
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | FDA class 2 | Cardiovascular |
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Other Clearances by R4 Vascular, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K121385 | VECTOR | Jun 14, 2012 | Substantially Equivalent |
| K100169 | DURASPAN HEMODIALYSIS LONG-TERM CATHETER | Feb 18, 2010 | Unknown |
| K091506 | DURASPAN HEMODIALYSIS LONG-TERM CATHETER, MODELS 62152420, 621512820, 62153220, 62153620, 62154020, 62155520 | Jan 8, 2010 | Unknown |
| K092040 | PHEROCIOUS 10.5 FR (24 CM, 28 CM AND 32 CM), MODELS 430102440, 430102840, 430103240 | Nov 18, 2009 | Substantially Equivalent |
| K083763 | ZEUS CT PICC 4 FR AND 5 FR SINGLE AND DUAL LUMEN | Mar 16, 2009 | Substantially Equivalent |
| K071361 | R4 VASCULAR INC. PEGASUS CT PICC, MODEL 500005-001,002, 004, 005, 500004-001, 002,004,005 | Aug 20, 2007 | Substantially Equivalent |