The Niner Nitinol Guidewire
FDA 510(k) K952860 · Microvena Corp.
510(k) numberK952860
Submission
- Device name
- The Niner Nitinol Guidewire
- Applicant
- Microvena Corp.
White Bear Lake, MN, US - Received
- June 22, 1995
- Decision date
- December 13, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQX – Wire, Guide, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1330
- Specialty
- Cardiovascular
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| K251385 | InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire…DQX · Traditional | Merit Medical Ireland, Ltd. | 01/21/2026SE |
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More from Solo Pace, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K991898 | Ultra-Select Guidewire, Hytek GuidewireDQX · Special | 06/16/1999SE |
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| K982657 | Amplatz Thrombectomy Device Models Atd 601, Atd 602, Atd 801, Atd 802, Foot Pedal…MCW · Traditional | 11/18/1998SE |
| K970668 | The Amplantz Goose Neck MicrosnareDQY · Traditional | 06/10/1998SE |
| K972511 | Amplatz Goose Neck Snare Kit/ CatheterDXE · Traditional | 03/06/1998SE |
| K971984 | Amplatz Thrombectomy Device(Atd 603,602,801,802)/FOOT Pedal Assembly(Ak 200)MCW · Traditional | 09/19/1997SE |
| K954642 | Hydro-Select GuidewireDQX · Traditional | 12/17/1996SE |
| K954205 | The Amplatz Thrombectomy DeviceMCW · Traditional | 08/13/1996SE |
| K955304 | CricketDQX · Traditional | 05/16/1996SE |
| K946356 | M-Path Nitinol GuidewireDQX · Traditional | 03/31/1995SE |
Questions and answers
When was The Niner Nitinol Guidewire cleared by the FDA?
The Niner Nitinol Guidewire (K952860) received a 510(k) decision of Substantially Equivalent on December 13, 1995, 174 days after the submission was received.
What is the product code of K952860?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.