FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS
K Number: K021591
·
Decision May 22, 2002
Classifications
1
FEI Numbers
147
Registration Numbers
147
Same Product Code
174
Applicant Total
37
Review Days
7
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Basic Information
- Device Name
- PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS
- K Number
- K021591
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cordis Neurovascular, Inc.
- Date Received
- May 15, 2002
- Decision Date
- May 22, 2002
- Product Code
- KRA
- 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 |
|---|---|---|---|
| KRA | Catheter, Continuous Flush | FDA class 2 | Cardiovascular |
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Other Clearances by Cordis Neurovascular, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K082324 | TRUFILL DCS SYRINGE | Sep 12, 2008 | Substantially Equivalent |
| K080967 | TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRUFILL DCS SYRINGE II, ALSO KNOWN AS THE TRUFILL DCS ORBIT | May 2, 2008 | Substantially Equivalent |
| K071962 | VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS AND TRUPUSH COIL PUSHER) | Sep 26, 2007 | Substantially Equivalent |
| K070279 | MODIFICATION TO HYPERTRANSIT INFUSION CATHETER | Mar 14, 2007 | Substantially Equivalent |
| K063254 | THE TRUFILL DCS DETACHABLE COIL SYSTEM; THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM | Dec 7, 2006 | Substantially Equivalent |
| K053197 | TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION | Dec 15, 2005 | Substantially Equivalent |
| K043538 | HYPERTRANSIT INFUSION CATHETER | Apr 18, 2005 | Substantially Equivalent |
| K032553 | TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM | Sep 23, 2003 | Substantially Equivalent |
| K030963 | TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM | Jun 20, 2003 | Substantially Equivalent |
| K020680 | PROWLER SELECT 10 AND 14 INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS | Mar 27, 2002 | Substantially Equivalent |