ENPATH DEFLECTABLE CATHETER
FDA 510(k) clearance K043489 · decided 2005-05-19
Clearance details
- K-number
- K043489
- Device name
- ENPATH DEFLECTABLE CATHETER
- Applicant
- Enpath Medical Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2004-12-17
- Decision date
- 2005-05-19
- Days to decision
- 153 days
- Clearance type
- Traditional
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Channel Steerable Sheath in 8F Enpath part # 10775-003, BARD Part Number XD10775003 (US Di recall (Z-0118-2007) | Enpath Medical, Inc. | 2006-11-02 |
| Enpath Steerable Sheath, model 10775-003, Sterile EO. Single Use Only. Enpath Medical, Inc recall (Z-1573-05) | Enpath Medical, Inc. | 2005-09-21 |