HeartLight Deflectable Sheath
FDA 510(k) clearance K152310 · decided 2016-02-24
Clearance details
- K-number
- K152310
- Device name
- HeartLight Deflectable Sheath
- Applicant
- Cardiofocus, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-08-14
- Decision date
- 2016-02-24
- Days to decision
- 194 days
- Clearance type
- Traditional
- Product code
- DRA
- Device class
- 2
- Regulation number
- 870.1280
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Marlborough, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HeartLight Catheter, HeartLight X3 Console V2 (P150026/S015) | Cardiofocus, Inc. | 2023-08-11 |
| HeartLight Catheter, HeartLight X3 Console V2 (P150026/S014) | Cardiofocus, Inc. | 2023-02-24 |
| HeartLight® X3 Catheter with Excalibur Balloon (P150026/S013) | Cardiofocus, Inc. | 2022-04-02 |
| HeartLight X3 Endoscopic Ablation System (P150026/S012) | Cardiofocus, Inc. | 2021-04-06 |
| HeartLight Catheter and HeartLight Console (P150026/S011) | Cardiofocus, Inc. | 2020-07-01 |
| HeartLight Endoscopic Ablation System (P150026/S008) | Cardiofocus, Inc. | 2020-05-08 |
| HeartLight System (P150026/S010) | Cardiofocus, Inc. | 2020-02-20 |
| HeartLight System (P150026/S009) | Cardiofocus, Inc. | 2020-01-16 |