DUETT PRO MODEL 1010 AND DIAGNOSTIC DUETT PRO MODEL 2210
FDA premarket approval P990037/S020 · decided 2003-07-11
Approval details
- PMA number
- P990037
- Supplement
- S020
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DUETT PRO MODEL 1010 AND DIAGNOSTIC DUETT PRO MODEL 2210
- Generic name
- Device, hemostasis, vascular
- Applicant
- Vascular Solutions, Inc.
- Date received
- 2003-06-18
- Decision date
- 2003-07-11
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- CHANGE IN THE TENSILE TEST METHOD, WHICH TESTS THE FUNCTIONALITY OF THE CATHETER USING A METHOD THAT ALIGNS IT WITH THE REQUIRED SPECIFICATION.
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510(k) clearances by this applicant
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|---|---|---|
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| Raider Guidewire (K173532) | Vascular Solutions, Inc. | 2017-12-15 |
| Octane aspiration system (K173266) | Vascular Solutions, Inc. | 2017-12-01 |