Cruiser 18 Guidewire
FDA 510(k) K102211 · Brivant, Ltd.
510(k) numberK102211
Submission
- Device name
- Cruiser 18 Guidewire
- Applicant
- Brivant, Ltd.
Galway, IE - Received
- August 5, 2010
- Decision date
- September 3, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K253746 | Enroute 0.014'' Transcarotid GuidewireDQX · Special | Lake Region Medical | 03/19/2026SE |
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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 |
|---|---|---|
| K141831 | Hydraview GuidewireDQX · Traditional | 09/04/2014SE |
| K122856 | Charter GuidewireDQX · Special | 10/17/2012SE |
| K120137 | Victory Guidewire (32 Models)DQX · Special | 02/14/2012SE |
| K103377 | Charter Guidewire Model 45-281, 45-282, 45-283DQX · Special | 05/18/2011SE |
| K093515 | 3 Piece Parodi Guidewire System ( Long Cut Outer with Long Taper .014) Short Taper, 2…DQX · Traditional | 02/16/2010SE |
| K083094 | Streamer Polymer GuidewireDQX · Traditional | 07/07/2009SE |
| K073082 | CPS Courier GuidewireDQX · Special | 01/09/2008SE |
| K060551 | Brivant GuidewireDQX · Traditional | 06/07/2006SE |
Questions and answers
When was Cruiser 18 Guidewire cleared by the FDA?
Cruiser 18 Guidewire (K102211) received a 510(k) decision of Substantially Equivalent on September 3, 2010, 29 days after the submission was received.
What is the product code of K102211?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.