PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT
FDA 510(k) clearance K040415 · decided 2004-04-14
Clearance details
- K-number
- K040415
- Device name
- PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT
- Applicant
- Synovis Surgical Innovations
- Decision
- Substantially Equivalent
- Date received
- 2004-02-18
- Decision date
- 2004-04-14
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- DXZ
- Device class
- 2
- Regulation number
- 870.3470
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- St. Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| PSD Gel that's provided with Peri-Strips Dry Staple Line Reinforcement with Apex Processin recall (Z-2447-2010) | Synovis Surgical Inovation Div. of | 2010-09-21 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| DARDIK BIOGRAFT(R) MOD. HUMAN UMBILICAL VEIN GRAFT (P780002/S012) | Synovis Surgical Innovations | 1995-11-24 |
| DARDIK BIOGRAFT FOR PERIPHERAL & AV ACCESS USE (P780002/S008) | Synovis Surgical Innovations | 1990-09-11 |
| DARDIK BIOGRAFT (P780002/S005) | Synovis Surgical Innovations | 1986-05-19 |
| DARDIK BIOGRAFT (P780002/S002) | Synovis Surgical Innovations | 1981-12-01 |
| DARDIK BIOGRAFT (P780002/S004) | Synovis Surgical Innovations | 1981-11-30 |
| DARDIK BIOGRAFT FOR USE IN PERIPHERAL VASCULAR SUR (P780002/S001) | Synovis Surgical Innovations | 1981-07-10 |
| DARDIK BIOGRAFT (P780002) | Synovis Surgical Innovations | 1979-01-17 |