FDA Registration
Active
🇺🇸 United States
CPS Direct PL Peelable Outer Guide Catheter, Accessory Valve Bypass Tools
Reg #: 3013288201
·
FEI: 3013288201
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ABBOTT MEDICAL
- Registration Number
- 3013288201
- FEI Number
- 3013288201
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 14901 Deveau Pl. Building 2
- City
- Minnetonka
- State
- MN
- ZIP
- 55345
- Country
- US
Regulatory Submissions
- 510(k) Number
- K061710
Owner / Operator
- Firm Name
- ABBOTT LABORATORIES
- Operator Number
- 1415939
- Address
- 100 ABBOTT PARK RD., D-03Q3, AP52-1
- City
- Abbott Park
- State
- IL
- Postal Code
- 60064
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2008-12-12 |
Proprietary Names
CPS Direct PL Peelable Outer Guide Catheter, Accessory Valve Bypass Tools
410170, 410171, 410172, 410173, 410174, 410175, 410176, 410177, 410180, 410181, 410182, 410183, 410184, 410185
410220, 410221, 410222, 410223, 410225, 410193, 410194
410186, 410187, 410210, 410211, 410212, 410213, 410214, 410215, 410216, 410224, 410217, 410218, 410219
Establishment Types
Manufacture Medical Device