MODIFICATION TO BRAIDED GUIDING INTRODUCER SYSTEM
FDA 510(k) clearance K040713 · decided 2004-06-01
Clearance details
- K-number
- K040713
- Device name
- MODIFICATION TO BRAIDED GUIDING INTRODUCER SYSTEM
- Applicant
- Thomas Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-03-18
- Decision date
- 2004-06-01
- Days to decision
- 75 days
- Clearance type
- Special
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Malvern, PA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Thomas Medical Products
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.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Transseptal Sheath Introducer Kits (under trade names: HeartSpan, Channel FX, Torflex, Bra recall (Z-0815-2010) | Thomas Medical Products Inc | 2010-03-04 |