Safesept Transseptal Trocar Guidewire
FDA 510(k) K081986 · Oscor, Inc.
510(k) numberK081986
Submission
- Device name
- Safesept Transseptal Trocar Guidewire
- Applicant
- Oscor, Inc.
Palm Harbor, FL, US - Received
- July 14, 2008
- Decision date
- November 14, 2008
- 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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| 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 |
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| K130633 | Introducer Sets, Model Adelante RadialDYB · Traditional | 02/13/2014SE |
| K130843 | Safesept Needle Free Transseptal Trocar GuidewireDRC · Traditional | 01/08/2014SE |
| K130104 | Guidewire, Pursuer SeriesDQX · Traditional | 06/13/2013SE |
| K122960 | Steerable Guiding Sheath, Model Adelante DestinoDYB · Traditional | 12/13/2012SE |
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Questions and answers
When was Safesept Transseptal Trocar Guidewire cleared by the FDA?
Safesept Transseptal Trocar Guidewire (K081986) received a 510(k) decision of Substantially Equivalent on November 14, 2008, 123 days after the submission was received.
What is the product code of K081986?
The FDA product code is DRC – Trocar, a Class II (moderate risk) device regulated under 21 CFR 870.1390.