Transseptal Needle/Trocar
FDA 510(k) K011727 · Thomas Medical Products, Inc.
510(k) numberK011727
Submission
- Device name
- Transseptal Needle/Trocar
- Applicant
- Thomas Medical Products, Inc.
Malvern, PA, US - Received
- June 4, 2001
- Decision date
- May 2, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRC – Trocar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1390
- Specialty
- Cardiovascular
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| K241042 | SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)DRC · Special | Pressure Products Medical Device Manufacturing… | 05/17/2024SE |
| K221707 | SafeSept® Transseptal Guidewire (SS-140)DRC · Special | Pressure Products Medical Device Manufacturing… | 09/14/2022SE |
| K212625 | PathBuilder Transseptal NeedleDRC · Traditional | Shanghai Microport EP Medtech Co., Ltd. | 03/23/2022SE |
| K210328 | SafeSept Blunt NeedleDRC · Special | Pressure Products Medical Device Manufacturing… | 03/05/2021SE |
| K172950 | TSN Transseptal NeedleDRC · Traditional | Pressure Products Medical Device Manufacturing… | 02/21/2018SE |
| K172934 | Needle Free Transseptal CannulaDRC · Traditional | Pressure Products Medical Device Manufacturing… | 02/16/2018SE |
| K172893 | SafeSept Needle Free Transseptal GuidewireDRC · Traditional | Pressure Products Medical Device Manufacturing… | 12/21/2017SE |
| K170671 | SafeSept Transseptal GuidewireDRC · Traditional | Pressure Products Medical Device Manufacturing… | 10/20/2017SE |
| K132943 | Intracardic Catheter Introducer Kit and Transseptal NeedleDRC · Traditional | Synaptic Medical Limited | 08/29/2014SE |
More from Synaptic Medical Limited
| 510(k) | Device | Decision |
|---|---|---|
| K122431 | Heartspan Steerable Introducer KitDYB · Traditional | 01/29/2013SE |
| K120158 | Coronary Sinus Guide and Lateral Vein Introducer KitsDYB · Traditional | 08/14/2012SE |
| K101015 | Guide Catheters and AccessoriesDQY · Traditional | 09/23/2010SE |
| K083269 | CrossoverDYB · Traditional | 02/03/2009SE |
| K081341 | Reinforced Catheter Introducer System (Rcis)DYB · Traditional | 05/14/2008SE |
| K072745 | Y-GlideDTL · Special | 01/04/2008SE |
| K043438 | Large Bore Splittable Introducer KitDYB · Special | 02/15/2005SE |
| K040713 | Modification to Braided Guiding Introducer SystemDYB · Special | 06/01/2004SE |
| K020090 | Modification to Transseptal Introducer SetDYB · Special | 02/11/2002SE |
| K013202 | Modification to Braided Guiding IntroducerDYB · Special | 10/23/2001SE |
Questions and answers
When was Transseptal Needle/Trocar cleared by the FDA?
Transseptal Needle/Trocar (K011727) received a 510(k) decision of Substantially Equivalent on May 2, 2002, 332 days after the submission was received.
What is the product code of K011727?
The FDA product code is DRC – Trocar, a Class II (moderate risk) device regulated under 21 CFR 870.1390.