VERITAS COLLAGEN MATRIX
FDA 510(k) clearance K030879 · decided 2003-04-24
Clearance details
- K-number
- K030879
- Device name
- VERITAS COLLAGEN MATRIX
- Applicant
- Synovis Surgical Innovations
- Decision
- Substantially Equivalent
- Date received
- 2003-03-20
- Decision date
- 2003-04-24
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- OXE
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- St. Paul, MN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Synovis Surgical Innovations
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Biodesign Staple Line Reinforcement (K170945) | Cook Biotech Incorporated | 2017-04-28 |
| Kerecis SecureMesh (K153364) | Kerecis Limited | 2016-08-19 |
| SURGISIS STAPLE LINE REINFORCEMENT (K022044) | Cook Biotech, Inc. | 2002-08-23 |
Recalls involving this device
No recalls on record reference this clearance.
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 |