ATHEROCATH-BANTAM(TM) DIRECTIONAL CORONARY ATHERECTOMY SYSTEM
FDA premarket approval P890043/S032 · decided 1998-06-08
Approval details
- PMA number
- P890043
- Supplement
- S032
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ATHEROCATH-BANTAM(TM) DIRECTIONAL CORONARY ATHERECTOMY SYSTEM
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Applicant
- Abbott Vascular
- Date received
- 1997-07-09
- Decision date
- 1998-06-08
- Days to decision
- 334 days
- Decision code
- APPR
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- Approval for a change in the biological indicator incubation time from 7 to 5 days.
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510(k) clearances by this applicant
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|---|---|---|
| NC TREK NEO Coronary Dilatation Catheter (K220634) | Abbott Vascular | 2022-06-30 |
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| HI-TORQUE Steelcore Bare Guide Wire (K200144) | Abbott Vascular | 2020-04-08 |
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| HI-TORQUE TurnTrac Guide Wire Family (K173795) | Abbott Vascular | 2018-01-12 |