SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX)
FDA 510(k) clearance K122937 · decided 2012-12-14
Clearance details
- K-number
- K122937
- Device name
- SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX)
- Applicant
- Cook, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-09-24
- Decision date
- 2012-12-14
- Days to decision
- 81 days
- Clearance type
- Special
- Product code
- DQO
- Device class
- 2
- Regulation number
- 870.1200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Bloomington, IN, US
- Third-party review
- No
- Expedited review
- No
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| Zenith AAA Endovascular Graft (P020018/S059) | Cook, Inc. | 2020-10-08 |
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