DRC — Trocar Class II
FDA product code DRC covers "Trocar", a Class II medical device regulated under 21 CFR 870.1390. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DRC
- Device Class
- Class II
- Regulation Number
- 870.1390
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K240246 | synaptic medical corporation | Accusafe Transseptal Guidewire (GTR31180, GTR31230) | July 26, 2024 |
| K241042 | pressure products medical device manufacturing | SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) | May 17, 2024 |
| K221707 | pressure products medical device manufacturing | SafeSept® Transseptal Guidewire (SS-140) | September 14, 2022 |
| K212625 | shanghai microport ep medtech co | PathBuilder Transseptal Needle | March 23, 2022 |
| K210328 | pressure products medical device manufacturing | SafeSept Blunt Needle | March 5, 2021 |
| K172950 | pressure products medical device manufacturing | TSN Transseptal Needle | February 21, 2018 |
| K172934 | pressure products medical device manufacturing | Needle Free Transseptal Cannula | February 16, 2018 |
| K172893 | pressure products medical device manufacturing | SafeSept Needle Free Transseptal Guidewire | December 21, 2017 |
| K170671 | pressure products medical device manufacturing | SafeSept Transseptal Guidewire | October 20, 2017 |
| K132943 | synaptic medical limited | INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE | August 29, 2014 |
| K130843 | oscor | SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE | January 8, 2014 |
| K122587 | st jude medical | BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208 | February 7, 2013 |
| K122832 | great batch medical | MOBICATH TRANSSEPTAL NEEDLE | December 19, 2012 |
| K111644 | great batch medical | MOBICATH TRANSSEPTAL NEEDLE | October 3, 2011 |
| K081986 | oscor | SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE | November 14, 2008 |
| K072278 | st jude medical | BRK TRANSSEPTAL NEEDLE | September 13, 2007 |
| K061070 | hansen medical | HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR | October 13, 2006 |
| K022117 | merit medical systems | MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SH | October 11, 2002 |
| K022257 | vomed volzer medizintechnik gmbh and | VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006 XXX-9011 | October 4, 2002 |
| K011727 | thomas medical products | TRANSSEPTAL NEEDLE/TROCAR | May 2, 2002 |