FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM
K Number: K030742
·
Decision Aug 29, 2003
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
402
Applicant Total
7
Review Days
172
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Basic Information
- Device Name
- POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM
- K Number
- K030742
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cryo Vascular Systems, Inc.
- Date Received
- March 10, 2003
- Decision Date
- August 29, 2003
- 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 Cryo Vascular Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K051916 | POLAR CATH PERIPHERAL DILATATION SYSTEM | Aug 5, 2005 | Substantially Equivalent |
| K042230 | POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM | Nov 5, 2004 | Substantially Equivalent |
| K042541 | MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM | Oct 12, 2004 | Substantially Equivalent |
| K033622 | POLARCATH PERIPHERAL DILATATION SYSTEM | Feb 10, 2004 | Substantially Equivalent |
| K023463 | CVSI PERIPHERAL BALLOON CATHETER; CVSI CATHETER INFLATION UNIT | Feb 19, 2003 | Substantially Equivalent |
| K022061 | CVSI PERIPHERAL BALLOON CATHETER; CVSI INFLATER | Sep 20, 2002 | Substantially Equivalent |