Combowire Pressure and Flow Guide Wire, Combotip Pressure and Flow Guide Wire
FDA 510(k) K042996 · Volcano Therapeutics, Inc.
510(k) numberK042996
Submission
- Device name
- Combowire Pressure and Flow Guide Wire, Combotip Pressure and Flow Guide Wire
- Applicant
- Volcano Therapeutics, Inc.
Rancho Cordova,, CA, US - Received
- November 1, 2004
- Decision date
- November 24, 2004
- 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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| K261640 | Merit MAK Nitinol/Gold-Tungsten Guide WireDQX · Special | Merit Medical Ireland , Ltd. | 07/13/2026SE |
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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 |
| K253847 | Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)DQX · Special | Merit Medical Ireland, Ltd. | 01/31/2026SE |
| 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 |
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Questions and answers
When was Combowire Pressure and Flow Guide Wire, Combotip Pressure and Flow Guide Wire cleared by the FDA?
Combowire Pressure and Flow Guide Wire, Combotip Pressure and Flow Guide Wire (K042996) received a 510(k) decision of Substantially Equivalent on November 24, 2004, 23 days after the submission was received.
What is the product code of K042996?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.