INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE
FDA 510(k) clearance K132943 · decided 2014-08-29
Clearance details
- K-number
- K132943
- Device name
- INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE
- Applicant
- Synaptic Medical Limited
- Decision
- Substantially Equivalent
- Date received
- 2013-09-19
- Decision date
- 2014-08-29
- Days to decision
- 344 days
- Clearance type
- Traditional
- Product code
- DRC
- Device class
- 2
- Regulation number
- 870.1390
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Shanghai, CN
- 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.
| Record | Firm | Date |
|---|---|---|
| Accusafe Transseptal Guidewire (GTR31180, GTR31230) (K240246) | Synaptic Medical Corporation | 2024-07-26 |
| SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) (K241042) | Pressure Products Medical Device Manufacturing, LLC | 2024-05-17 |
| SafeSept® Transseptal Guidewire (SS-140) (K221707) | Pressure Products Medical Device Manufacturing, LLC | 2022-09-14 |
| PathBuilder Transseptal Needle (K212625) | Shanghai Microport EP Medtech Co., Ltd. | 2022-03-23 |
| SafeSept Blunt Needle (K210328) | Pressure Products Medical Device Manufacturing, LLC | 2021-03-05 |
| TSN Transseptal Needle (K172950) | Pressure Products Medical Device Manufacturing, LLC | 2018-02-21 |
| Needle Free Transseptal Cannula (K172934) | Pressure Products Medical Device Manufacturing, LLC | 2018-02-16 |
| SafeSept Needle Free Transseptal Guidewire (K172893) | Pressure Products Medical Device Manufacturing, LLC | 2017-12-21 |
| SafeSept Transseptal Guidewire (K170671) | Pressure Products Medical Device Manufacturing, LLC | 2017-10-20 |
| SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE (K130843) | Oscor, Inc. | 2014-01-08 |
| BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208 (K122587) | St Jude Medical | 2013-02-07 |
| MOBICATH TRANSSEPTAL NEEDLE (K122832) | Great Batch Medical | 2012-12-19 |
Recalls involving this device
No recalls on record reference this clearance.