Trak Back II
FDA 510(k) K003938 · Jomed, Inc.
510(k) numberK003938
Submission
- Device name
- Trak Back II
- Applicant
- Jomed, Inc.
Rockville, MD, US - Received
- December 20, 2000
- Decision date
- January 18, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
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| K242420 | pNOVUS 21 MicrocatheterDQO · Traditional | Phenox, Ltd. | 11/12/2024SE |
| K233268 | Impress Angiographic CatheterDQO · Special | Merit Medical Systems, Inc. | 05/22/2024SE |
| K233975 | Zoom 6F Insert CathetersDQO · Traditional | Imperative Care, Inc. | 04/02/2024SE |
| K232536 | Soldier MicrocatheterDQO · Traditional | Embolx, Inc. | 02/23/2024SE |
| K232573 | INFINITI Ambi Angiographic CatheterDQO · Traditional | Cordis US Corp | 11/21/2023SE |
More from Cordis US Corp
| 510(k) | Device | Decision |
|---|---|---|
| K031346 | Jovus Eagle Eye F/X 2.9F Ivus Catheter, Model 85900OBJ · Special | 06/23/2003SE |
| K031148 | In-Vision Imaging SystemDXK · Special | 05/28/2003SE |
| K031277 | Jowire Asahi Ptca Catheter Guide Wires, Models AG145300,141300,142300,132200,14M350,14M34…DQX · Special | 05/14/2003SE |
| K030053 | Jostent Selfx, Models 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810FGE · Traditional | 03/31/2003SE |
| K022762 | Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000, AG141002…DQX · Traditional | 12/16/2002SE |
| K021219 | Smartwire/Smartmap Pressure SystemDQX · Special | 05/17/2002SE |
| K020854 | Modification to Fox Pta CatheterLIT · Special | 04/11/2002SE |
| K010838 | Fox Pta Catheter, 3.0, 4.0, 5.0, 6.0, 7.0, and 8.0 X 40 MM, Models A14003, A14004…DQY · Traditional | 06/21/2001SE |
Questions and answers
When was Trak Back II cleared by the FDA?
Trak Back II (K003938) received a 510(k) decision of Substantially Equivalent on January 18, 2001, 29 days after the submission was received.
What is the product code of K003938?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.