2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER
FDA 510(k) clearance K130687 · decided 2013-08-15
Clearance details
- K-number
- K130687
- Device name
- 2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER
- Applicant
- Medical Components, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-03-13
- Decision date
- 2013-08-15
- Days to decision
- 155 days
- Clearance type
- Traditional
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Harleysville, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouc recall (Z-1924-2016) | Medical Components, Inc dba MedComp | 2016-06-07 |