Mobicath Transseptal Needle
FDA 510(k) K122832 · Great Batch Medical
510(k) numberK122832
Submission
- Device name
- Mobicath Transseptal Needle
- Applicant
- Great Batch Medical
Plymouth, MN, US - Received
- September 17, 2012
- Decision date
- December 19, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K181855 | RadialSeal Introducer KitDYB · Traditional | 07/26/2018SE |
| K130559 | Mobicath Bi-Directional Guiding SheathDYB · Special | 05/24/2013SE |
| K112541 | Z FLEX-270TM Steerable SheathDRA · Traditional | 02/07/2012SE |
| K110051 | Radialsource Transradial Access Introducer KitDYB · Traditional | 02/02/2012SE |
| K111644 | Mobicath Transseptal NeedleDRC · Traditional | 10/03/2011SE |
| K101784 | Mobicath Bi-Directional Guiding Sheath Model 1000182-XXXDYB · Traditional | 11/26/2010SE |
| K102540 | PTFE Portable IntroducerDYB · Special | 11/16/2010SE |
| K093232 | Optiseal Enpath Valved PTFE Peelable IntroducerDYB · Traditional | 03/15/2010SE |
| K093023 | PTFE Peelable IntroducerDYB · Special | 10/29/2009SE |
Questions and answers
When was Mobicath Transseptal Needle cleared by the FDA?
Mobicath Transseptal Needle (K122832) received a 510(k) decision of Substantially Equivalent on December 19, 2012, 93 days after the submission was received.
What is the product code of K122832?
The FDA product code is DRC – Trocar, a Class II (moderate risk) device regulated under 21 CFR 870.1390.