REF. 4102CV INTERMEDIARY TUBING, REF. 4509CV STERILE ZONE KIT
FDA 510(k) clearance K951843 · decided 1995-07-14
Clearance details
- K-number
- K951843
- Device name
- REF. 4102CV INTERMEDIARY TUBING, REF. 4509CV STERILE ZONE KIT
- Applicant
- Future Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-04-20
- Decision date
- 1995-07-14
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- HRX
- Device class
- 2
- Regulation number
- 888.1100
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- New York City, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| DePuy Mitek FMS Intermediary Tubing with One-Way valve Product Code: 281142 Product Usage: recall (Z-0191-2014) | DePuy Mitek, Inc., a Johnson & Johnson Co. | 2013-11-08 |
| DePuy Mitek FMS Irrigation Intermediary Tube With One-way Valve Arthroscopy tubing Product recall (Z-1946-2011) | DePuy Mitek, Inc., a Johnson & Johnson Co. | 2011-04-12 |
| DePuy Mitek FMS Irrigation Intermediary Tube Without One-way Valve Arthroscopy tubing (100 recall (Z-1948-2011) | DePuy Mitek, Inc., a Johnson & Johnson Co. | 2011-04-12 |