SafeSept Transseptal Guidewire
FDA 510(k) K170671 · Pressure Products Medical Device Manufacturing, LLC
510(k) numberK170671
Submission
- Device name
- SafeSept Transseptal Guidewire
- Applicant
- Pressure Products Medical Device Manufacturing, LLC
Morton, PA, US - Received
- March 6, 2017
- Decision date
- October 20, 2017
- 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
Other 510(k)s with product code DRC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240246 | Accusafe Transseptal Guidewire (GTR31180, GTR31230)DRC · Traditional | Synaptic Medical Corporation | 07/26/2024SE |
| 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 |
| K132943 | Intracardic Catheter Introducer Kit and Transseptal NeedleDRC · Traditional | Synaptic Medical Limited | 08/29/2014SE |
| K130843 | Safesept Needle Free Transseptal Trocar GuidewireDRC · Traditional | Oscor, Inc. | 01/08/2014SE |
More from Oscor, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253799 | SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135…DXF · Special | 03/13/2026SE |
| K241042 | SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)DRC · Special | 05/17/2024SE |
| K221707 | SafeSept® Transseptal Guidewire (SS-140)DRC · Special | 09/14/2022SE |
| K210328 | SafeSept Blunt NeedleDRC · Special | 03/05/2021SE |
| K181031 | TSI Transseptal IntroducerDYB · Traditional | 10/26/2018SE |
| K172950 | TSN Transseptal NeedleDRC · Traditional | 02/21/2018SE |
| K172934 | Needle Free Transseptal CannulaDRC · Traditional | 02/16/2018SE |
| K172893 | SafeSept Needle Free Transseptal GuidewireDRC · Traditional | 12/21/2017SE |
Questions and answers
When was SafeSept Transseptal Guidewire cleared by the FDA?
SafeSept Transseptal Guidewire (K170671) received a 510(k) decision of Substantially Equivalent on October 20, 2017, 228 days after the submission was received.
What is the product code of K170671?
The FDA product code is DRC – Trocar, a Class II (moderate risk) device regulated under 21 CFR 870.1390.