PERMANENT LEAD INTRADUCER
FDA 510(k) clearance K791129 · decided 1979-07-17
Clearance details
- K-number
- K791129
- Device name
- PERMANENT LEAD INTRADUCER
- Applicant
- Daig Corp.
- Decision
- Substantially Equivalent
- Date received
- 1979-06-14
- Decision date
- 1979-07-17
- Days to decision
- 33 days
- Clearance type
- Traditional
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| St. Jude Medical FAST-CATH Hemostasis Introducer 7F, REF 406702, Length 12 CM, Lot 6372 Ma recall (Z-2228-2009) | St. Jude Medical | 2009-09-18 |
| St. Jude Medical FAST-CATH Hemostasis Introducer 4F, REF 406709, Length 12 CM, Lot 4219 Ma recall (Z-2229-2009) | St. Jude Medical | 2009-09-18 |
| SJM Peel Away Introducer, REF 405116, Lot 2694227, Length 14 cm, 9F (3.00 mm), Max Guidewi recall (Z-1713-2009) | St. Jude Medical | 2009-08-17 |
| SJM Peel Away Introducer, REF 405153, Lot 2694252, Length 14 cm, 7F (2.33 mm), Max Guidewi recall (Z-1714-2009) | St. Jude Medical | 2009-08-17 |