Concentric Hydrophilic Guidewire, Models 90011, 90012
FDA 510(k) K003084 · Concentric Medical, Inc.
510(k) numberK003084
Submission
- Device name
- Concentric Hydrophilic Guidewire, Models 90011, 90012
- Applicant
- Concentric Medical, Inc.
Moutian View, CA, US - Received
- October 3, 2000
- Decision date
- May 16, 2001
- 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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| K253746 | Enroute 0.014'' Transcarotid GuidewireDQX · Special | Lake Region Medical | 03/19/2026SE |
| K253262 | EmeryGlide (EG18008901)DQX · Special | Nano4imaging GmbH | 03/06/2026SE |
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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 |
| K252674 | Solo Pace Fusion System (SOLOFUSE1)DQX · Traditional | Solo Pace, Inc. | 01/09/2026SE |
More from Solo Pace, Inc.
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| K173352 | Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever)POL · Traditional | 02/15/2018SE |
| K153729 | 8F FlowGate2 Balloon Guide CatheterDQY · Special | 01/27/2016SE |
| K150616 | Trevo XP ProVue Retriever (4x30mm)NRY · Traditional | 06/12/2015SE |
| K143077 | Trevo XP ProVue Retriever (6X25mm)NRY · Traditional | 04/06/2015SE |
| K133177 | Modified HD Guide CatheterDQY · Traditional | 02/25/2014SE |
| K133464 | Modified Trevo Provue RetrieverNRY · Special | 01/17/2014SE |
| K132641 | Modified Trevo Provue RetrieverNRY · Traditional | 01/13/2014SE |
| K131437 | Modified Concentric MicrocatheterDQO · Traditional | 10/11/2013SE |
| K131492 | Modified Flowgate Balloon Guide CatheterDQY · Traditional | 10/03/2013SE |
| K122581 | Modified Balloon Guide Catheter Model 90253, 90254DQY · Traditional | 11/21/2012SE |
Questions and answers
When was Concentric Hydrophilic Guidewire, Models 90011, 90012 cleared by the FDA?
Concentric Hydrophilic Guidewire, Models 90011, 90012 (K003084) received a 510(k) decision of Substantially Equivalent on May 16, 2001, 225 days after the submission was received.
What is the product code of K003084?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.