DRC · Trocar
Cardiovascular · 21 CFR 870.1390 · Class 2
Overview
| Product Code | DRC |
|---|---|
| Device Name | Trocar |
| Regulation | 21 CFR 870.1390 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula.
Classification Rationale
Class II (special controls). Except for trocars that are reprocessed for multiple use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Special Controls
*Classification.* Class II (special controls). Except for trocars that are reprocessed for multiple use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Recent Cleared Devices (20 of 51)
Showing 20 most recent of 51 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K240246 | Accusafe Transseptal Guidewire (GTR31180, GTR31230) | Synaptic Medical Corporation | Jul 26, 2024 | SESE |
| K241042 | SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) | Pressure Products Medical Device Manufacturing, LLC | May 17, 2024 | SESE |
| K221707 | SafeSept® Transseptal Guidewire (SS-140) | Pressure Products Medical Device Manufacturing, LLC | Sep 14, 2022 | SESE |
| K212625 | PathBuilder Transseptal Needle | Shanghai Microport EP Medtech Co., Ltd. | Mar 23, 2022 | SESE |
| K210328 | SafeSept Blunt Needle | Pressure Products Medical Device Manufacturing, LLC | Mar 5, 2021 | SESE |
| K172950 | TSN Transseptal Needle | Pressure Products Medical Device Manufacturing, LLC | Feb 21, 2018 | SESE |
| K172934 | Needle Free Transseptal Cannula | Pressure Products Medical Device Manufacturing, LLC | Feb 16, 2018 | SESE |
| K172893 | SafeSept Needle Free Transseptal Guidewire | Pressure Products Medical Device Manufacturing, LLC | Dec 21, 2017 | SESE |
| K170671 | SafeSept Transseptal Guidewire | Pressure Products Medical Device Manufacturing, LLC | Oct 20, 2017 | SESE |
| K132943 | INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE | Synaptic Medical Limited | Aug 29, 2014 | SESE |
| K130843 | SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE | Oscor, Inc. | Jan 8, 2014 | SESE |
| K122587 | BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208 | St Jude Medical | Feb 7, 2013 | SESE |
| K122832 | MOBICATH TRANSSEPTAL NEEDLE | Great Batch Medical | Dec 19, 2012 | SESE |
| K111644 | MOBICATH TRANSSEPTAL NEEDLE | Great Batch Medical | Oct 3, 2011 | SESE |
| K081986 | SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE | Oscor, Inc. | Nov 14, 2008 | SESE |
| K072278 | BRK TRANSSEPTAL NEEDLE | St Jude Medical | Sep 13, 2007 | SESE |
| K061070 | HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR | Hansen Medical, Inc. | Oct 13, 2006 | SESE |
| K022117 | MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-5 | Merit Medical Systems, Inc. | Oct 11, 2002 | SESE |
| K022257 | VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006 XXX-9011 XXX | Vomed Volzer Medizintechnik GmbH & Co. | Oct 4, 2002 | SESE |
| K011727 | TRANSSEPTAL NEEDLE/TROCAR | Thomas Medical Products, Inc. | May 2, 2002 | SESE |
Top Applicants
- Pressure Products Medical Device Manufacturing, LLC — 7 clearances
- Medical Device Technologies, Inc. — 3 clearances
- North American Instrument Corp. — 3 clearances
- Advance Medical Designs, Inc. — 2 clearances
- E-Z-Em, Inc. — 2 clearances
