Cronus Guidewire, Model 001-001470-1
FDA 510(k) K051373 · Stereotaxis, Inc.
510(k) numberK051373
Submission
- Device name
- Cronus Guidewire, Model 001-001470-1
- Applicant
- Stereotaxis, Inc.
Saint Louis, MO, US - Received
- May 26, 2005
- Decision date
- December 9, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NDQ – System, Catheter Or Guidewire, Steerable (Magnetic)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1290
- Specialty
- Cardiovascular
Other 510(k)s with product code NDQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K060967 | Niobe Magnetic Navigation System W/Navigant WorkstationNDQ · Traditional | Stereotaxis, Inc. | 10/19/2006SE |
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| K183027 | Steerable catheter control systemPJB · Traditional | 09/06/2019SE |
| K150312 | Vdrive system, Vdrive Duo, Vdrive with V-SonoDXX · Traditional | 06/17/2015SE |
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| K140804 | Vdrive with V-Loop/ Vdrive DuoDXX · Traditional | 09/03/2014SE |
Questions and answers
When was Cronus Guidewire, Model 001-001470-1 cleared by the FDA?
Cronus Guidewire, Model 001-001470-1 (K051373) received a 510(k) decision of Substantially Equivalent on December 9, 2005, 197 days after the submission was received.
What is the product code of K051373?
The FDA product code is NDQ – System, Catheter Or Guidewire, Steerable (Magnetic), a Class II (moderate risk) device regulated under 21 CFR 870.1290.