Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire
FDA 510(k) K152231 · Boston Scientific Corporation
510(k) numberK152231
Submission
- Device name
- Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire
- Applicant
- Boston Scientific Corporation
Maple Grove, MN, US - Received
- August 7, 2015
- Decision date
- February 12, 2016
- 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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| K261640 | Merit MAK Nitinol/Gold-Tungsten Guide WireDQX · Special | Merit Medical Ireland , Ltd. | 07/13/2026SE |
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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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| K261488 | OBSIDIO Conformable EmbolicKRD · Traditional | 07/24/2026SE |
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Questions and answers
When was Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire cleared by the FDA?
Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire (K152231) received a 510(k) decision of Substantially Equivalent on February 12, 2016, 189 days after the submission was received.
What is the product code of K152231?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.