510(k) K230283
- Device
- Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120, 405122, 405124, 405128, 405129, 405136, 405144, 405145, 405146, 405147, 405149, 405153, 405154, 405254, 405269, 405270, 405404, 405408, 405412, 405416, 405418, 405420, 405422, 405424, 405428)
- Applicant
- ABBOTT MEDICAL
- 510(k) number
- K230283
- Product code
- DYB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-03-01
- Date received
- 2023-02-01
- Regulation
- 870.1340
- Classification name
- Introducer, Catheter
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Chidalu Mozie
- Address
- 15900 Valley View Ct. Sylmar CA US 91342 91342
FDA Registration Numbers
- 3017168767
- 3010665433
- 1450662
- 3021951050
- 3004134316
- 3031983053
- 3043337628
- 3007697249
- 2521402
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Source Documents
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