FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CORDIS ENDOVASCULAR TEMPORARY OCCLUSION BALLOON CATHETER
K Number: K984214
·
Decision Aug 10, 1999
Classifications
1
FEI Numbers
186
Registration Numbers
186
Same Product Code
203
Applicant Total
37
Review Days
259
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Basic Information
- Device Name
- CORDIS ENDOVASCULAR TEMPORARY OCCLUSION BALLOON CATHETER
- K Number
- K984214
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4450
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cordis Neurovascular, Inc.
- Date Received
- November 24, 1998
- Decision Date
- August 10, 1999
- Product Code
- DXC
- 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 |
|---|---|---|---|
| DXC | Clamp, Vascular | FDA class 2 | Cardiovascular |
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|---|---|---|---|
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| 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 |
| K021591 | PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS | May 22, 2002 | Substantially Equivalent |