Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1390](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1390) → DRC — Trocar # DRC · Trocar _Cardiovascular · 21 CFR 870.1390 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRC ## Overview - **Product Code:** DRC - **Device Name:** Trocar - **Regulation:** [21 CFR 870.1390](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1390) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) ## 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](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRC/K240246.md) | Accusafe Transseptal Guidewire (GTR31180, GTR31230) | Synaptic Medical Corporation | Jul 26, 2024 | SESE | | [K241042](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRC/K241042.md) | SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) | Pressure Products Medical Device Manufacturing, LLC | May 17, 2024 | SESE | | [K221707](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRC/K221707.md) | SafeSept® Transseptal Guidewire (SS-140) | Pressure Products Medical Device Manufacturing, LLC | Sep 14, 2022 | SESE | | [K212625](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRC/K212625.md) | PathBuilder Transseptal Needle | Shanghai Microport EP Medtech Co., Ltd. | Mar 23, 2022 | SESE | | [K210328](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRC/K210328.md) | SafeSept Blunt Needle | Pressure Products Medical Device Manufacturing, LLC | Mar 5, 2021 | SESE | | [K172950](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRC/K172950.md) | TSN Transseptal Needle | Pressure Products Medical Device Manufacturing, LLC | Feb 21, 2018 | SESE | | [K172934](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRC/K172934.md) | Needle Free Transseptal Cannula | Pressure Products Medical Device Manufacturing, LLC | Feb 16, 2018 | SESE | | [K172893](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRC/K172893.md) | SafeSept Needle Free Transseptal Guidewire | Pressure Products Medical Device Manufacturing, LLC | Dec 21, 2017 | SESE | | [K170671](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRC/K170671.md) | SafeSept Transseptal Guidewire | Pressure Products Medical Device Manufacturing, LLC | Oct 20, 2017 | SESE | | [K132943](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRC/K132943.md) | INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE | Synaptic Medical Limited | Aug 29, 2014 | SESE | | [K130843](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRC/K130843.md) | SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE | Oscor, Inc. | Jan 8, 2014 | SESE | | [K122587](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRC/K122587.md) | BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208 | St Jude Medical | Feb 7, 2013 | SESE | | [K122832](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRC/K122832.md) | MOBICATH TRANSSEPTAL NEEDLE | Great Batch Medical | Dec 19, 2012 | SESE | | [K111644](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRC/K111644.md) | MOBICATH TRANSSEPTAL NEEDLE | Great Batch Medical | Oct 3, 2011 | SESE | | [K081986](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRC/K081986.md) | SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE | Oscor, Inc. | Nov 14, 2008 | SESE | | [K072278](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRC/K072278.md) | BRK TRANSSEPTAL NEEDLE | St Jude Medical | Sep 13, 2007 | SESE | | [K061070](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRC/K061070.md) | HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR | Hansen Medical, Inc. | Oct 13, 2006 | SESE | | [K022117](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRC/K022117.md) | MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-5 | Merit Medical Systems, Inc. | Oct 11, 2002 | SESE | | [K022257](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRC/K022257.md) | VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006 XXX-9011 XXX | Vomed Volzer Medizintechnik GmbH & Co. | Oct 4, 2002 | SESE | | [K011727](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRC/K011727.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRC](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRC) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com