Duett Sealing Device (D-Stat Flowable)
FDA premarket approval P990037/S036 · decided 2022-11-04
Approval details
- PMA number
- P990037
- Supplement
- S036
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Duett Sealing Device (D-Stat Flowable)
- Generic name
- Device, hemostasis, vascular
- Applicant
- Vascular Solutions, Inc.
- Date received
- 2022-08-08
- Decision date
- 2022-11-04
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for minor design and manufacturing changes to the D-Stat Flowable device diluent vial and packaging sealed tray.
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510(k) clearances by this applicant
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|---|---|---|
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| Octane aspiration system (K173266) | Vascular Solutions, Inc. | 2017-12-01 |