Permanent Sled Bag
FDA 510(k) clearance K152403 · decided 2015-09-22
Clearance details
- K-number
- K152403
- Device name
- Permanent Sled Bag
- Applicant
- Boston Scientific
- Decision
- Substantially Equivalent
- Date received
- 2015-08-25
- Decision date
- 2015-09-22
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- ITX
- Device class
- 2
- Regulation number
- 892.1570
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Fremont, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.