Echomark Guidewire with Ultrasonic Localization
FDA 510(k) K922787 · Echocath, Inc.
510(k) numberK922787
Submission
- Device name
- Echomark Guidewire with Ultrasonic Localization
- Applicant
- Echocath, Inc.
Princeton, NJ, US - Received
- June 9, 1992
- Decision date
- January 6, 1993
- 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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| 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 |
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More from Solo Pace, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K010482 | Echoflow Portable Doppler Blood Flow Measurement System; Model PEF-1JOP · Special | 03/20/2001SE |
| K990642 | Echoflow Doppler Blood Velocity MeterJOP · Traditional | 09/16/1999SE |
| K932436 | Echomark Intrauterine Guiding CatheterMOV · Traditional | 11/16/1995SE |
| K933417 | Echomark(R) Electrophysiology CatheterDRF · Traditional | 05/04/1995SE |
| K926351 | Colormark(Tm) Visualization SystemIYN · Traditional | 09/16/1993SE |
Questions and answers
When was Echomark Guidewire with Ultrasonic Localization cleared by the FDA?
Echomark Guidewire with Ultrasonic Localization (K922787) received a 510(k) decision of Substantially Equivalent on January 6, 1993, 211 days after the submission was received.
What is the product code of K922787?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.