HeartLight System
FDA premarket approval P150026/S010 · decided 2020-02-20
Approval details
- PMA number
- P150026
- Supplement
- S010
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HeartLight System
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Applicant
- Cardiofocus, Inc.
- Date received
- 2020-01-22
- Decision date
- 2020-02-20
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- OAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Marlborough, MA
- Statement
- Implementation of a revised Nosecone Forming Fixture used in manufacturing of the HeartLight® family of Catheters.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| HeartLight Deflectable Sheath (K152310) | Cardiofocus, Inc. | 2016-02-24 |
| CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR (K013201) | Cardiofocus, Inc. | 2002-03-18 |
| MALLEABLE SURGICAL LIGHTSTIC 180, MODEL 180 (1CM-9CM) (K013901) | Cardiofocus, Inc. | 2001-12-20 |
| SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C (K011988) | Cardiofocus, Inc. | 2001-09-20 |
| SURGICAL LIGHTSTIC, MODELS, 180 L, AND 180 C (K993834) | Cardiofocus, Inc. | 2000-02-04 |