Accutrac XT Intravascular Guide Wire (Floppy) Model 2403/(FLEX) Model 2404
FDA 510(k) K961777 · Cardio Metrics, Inc.
510(k) numberK961777
Submission
- Device name
- Accutrac XT Intravascular Guide Wire (Floppy) Model 2403/(FLEX) Model 2404
- Applicant
- Cardio Metrics, Inc.
Mountain View, CA, US - Received
- May 7, 1996
- Decision date
- July 31, 1996
- 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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| 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 |
|---|---|---|
| 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 |
| K955551 | CARDI0METRICS Flow Wire XT Doppler Guide Model 1403, 1404DQX · Traditional | 02/28/1996SE |
| K954913 | Cardiometrics Accutrac Intravascular Guide Wire (Modification)DQX · Traditional | 11/07/1995SE |
| 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 Accutrac XT Intravascular Guide Wire (Floppy) Model 2403/(FLEX) Model 2404 cleared by the FDA?
Accutrac XT Intravascular Guide Wire (Floppy) Model 2403/(FLEX) Model 2404 (K961777) received a 510(k) decision of Substantially Equivalent on July 31, 1996, 85 days after the submission was received.
What is the product code of K961777?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.