FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVICE
K Number: K113103
·
Decision May 22, 2012
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
44
Applicant Total
13
Review Days
216
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Basic Information
- Device Name
- SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVICE
- K Number
- K113103
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rex Medical
- Date Received
- October 19, 2011
- Decision Date
- May 22, 2012
- Product Code
- PNO
- 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 |
|---|---|---|---|
| PNO | Catheter, Percutaneous, Cutting/Scoring | FDA class 2 | Cardiovascular |
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FDA 510(k)
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Other Clearances by Rex Medical
| K Number | Device Name | ||
|---|---|---|---|
| K120346 | CLEANER ROTATIONAL THROMBECTOMY SYSTEM | Jun 1, 2012 | Substantially Equivalent |
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| K081410 | OPTION VENA CAVA FILTER | Jun 4, 2009 | Substantially Equivalent |
| K071422 | 15.5F HEMO-STREAM HEMODIALYSIS CATHETER SET | Aug 22, 2007 | Unknown |
| K051468 | INNER-LOCK INTRODUCER SHEATH | Aug 4, 2005 | Substantially Equivalent |
| K040252 | CLEANER ROTATIONAL THROMBECTOMY SYSTEM KIT | Feb 26, 2004 | Substantially Equivalent |
| K033793 | CLEANER II ROTATIONAL THROMBECTOMY SYSTEM | Dec 16, 2003 | Substantially Equivalent |
| K032569 | SHORT INTRODUCER SHEATH | Sep 16, 2003 | Substantially Equivalent |
| K031610 | REX MEDICAL CLEANER ROTATIONAL THROMBECTOMY SYSTEM | May 27, 2003 | Substantially Equivalent |