TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE
FDA 510(k) clearance K033858 · decided 2004-07-12
Clearance details
- K-number
- K033858
- Device name
- TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE
- Applicant
- European Custom Manufacturing BV
- Decision
- Substantially Equivalent
- Date received
- 2003-12-11
- Decision date
- 2004-07-12
- Days to decision
- 214 days
- Clearance type
- Traditional
- Product code
- LDF
- Device class
- 2
- Regulation number
- 870.3680
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Gemert, NL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Temporary Pacing Wire, BIPOLAR, Models BM, V, VE and VF, Rx Only, STERILE/EO, Single use o recall (Z-1038-2012) | European Custom Manufacturing B.V. | 2012-02-15 |