CARDIOVASCULAR SPRING GUIDES
FDA 510(k) clearance K770977 · decided 1977-06-14
Clearance details
- K-number
- K770977
- Device name
- CARDIOVASCULAR SPRING GUIDES
- Applicant
- Lake Region Mfg., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-05-31
- Decision date
- 1977-06-14
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- DQX
- Device class
- 2
- Regulation number
- 870.1330
- 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 |
|---|---|---|
| Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard recall (Z-3062-2024) | Bard Peripheral Vascular Inc | 2024-09-06 |