Cardiometrics Accutrac Intravascular Guide Wire (Modification)
FDA 510(k) K954913 · Cardio Metrics, Inc.
510(k) numberK954913
Submission
- Device name
- Cardiometrics Accutrac Intravascular Guide Wire (Modification)
- Applicant
- Cardio Metrics, Inc.
Mountain View, CA, US - Received
- October 3, 1995
- Decision date
- November 7, 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
Other 510(k)s with product code DQX
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| K261281 | CROSSLEAD Standard 035 and CROSSLEAD Stiff 035DQX · Traditional | Filmecc Co., Ltd. | 09/03/2026SE |
| K253667 | Accoat Guide WireDQX · Traditional | Sp Medical A/S | 07/14/2026SE |
| K261640 | Merit MAK Nitinol/Gold-Tungsten Guide WireDQX · Special | Merit Medical Ireland , Ltd. | 07/13/2026SE |
| K254137 | InQwire Amplatz Guide WireDQX · Traditional | Merit Medical Ireland, Ltd. | 05/22/2026SE |
| K260544 | FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD…DQX · Special | FMD Co., Ltd. | 03/20/2026SE |
| 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 |
More from Solo Pace, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K972762 | Cardiometrics Flowire 300 and XT 300 Doppler Guide WiresDQX · Traditional | 10/14/1997SE |
| K965140 | Cardiometrics Wavewire/Wavemap Pressure SystemDQX · Traditional | 08/18/1997SE |
| K951567 | Cardiometics Flowire, Smartwire Doppler Guide WireITX · Traditional | 10/25/1996SE |
| K961777 | Accutrac XT Intravascular Guide Wire (Floppy) Model 2403/(FLEX) Model 2404DQX · Traditional | 07/31/1996SE |
| K955551 | CARDI0METRICS Flow Wire XT Doppler Guide Model 1403, 1404DQX · Traditional | 02/28/1996SE |
| K952562 | Cardiometrics Accutrac Intravascular Guide WireDQX · Traditional | 08/29/1995SE |
| K943022 | Cardiometrics Flowire Doppler Guide WireDQX · Traditional | 09/19/1994SE |
| K940984 | Cardiometrics Dualflow Switch BoxDQX · Traditional | 08/18/1994SE |
| K933320 | Cardiometrics Flomap and Flomod Ultrasound InstrumentIYO · Traditional | 08/17/1994SE |
| K941485 | Cardiometrics Flowire Doppler Guide WiresDQX · Traditional | 05/31/1994SE |
Questions and answers
When was Cardiometrics Accutrac Intravascular Guide Wire (Modification) cleared by the FDA?
Cardiometrics Accutrac Intravascular Guide Wire (Modification) (K954913) received a 510(k) decision of Substantially Equivalent on November 7, 1995, 35 days after the submission was received.
What is the product code of K954913?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.