510(k) K251014
- Device
- APRO 45 Catheter
- Applicant
- Alembic, LLC
- 510(k) number
- K251014
- Product code
- DQY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-05-01
- Date received
- 2025-04-02
- Regulation
- 870.1250
- Classification name
- Catheter, Percutaneous
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Stina Almaleh
- Address
- 627 National Ave. Mountain View CA US 94043 94043
FDA Registration Numbers
- 3017168767
- 3010665433
- 1450662
- 3021951050
- 3002807090
- 3027343398
- 2521402
- 3014687026
- 3012050423
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- 9617592
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- 1313046
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- 3004718255
- 3009564766
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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