Jowire Asahi Ptca Catheter Guide Wires, Models AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002
FDA 510(k) K031277 · Jomed, Inc.
510(k) numberK031277
Submission
- Device name
- Jowire Asahi Ptca Catheter Guide Wires, Models AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002
- Applicant
- Jomed, Inc.
Rancho Cordova,, CA, US - Received
- April 22, 2003
- Decision date
- May 14, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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More from Solo Pace, Inc.
| 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 |
| 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 |
| K003938 | Trak Back IIDQO · Special | 01/18/2001SE |
Questions and answers
When was Jowire Asahi Ptca Catheter Guide Wires, Models AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002 cleared by the FDA?
Jowire Asahi Ptca Catheter Guide Wires, Models AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002 (K031277) received a 510(k) decision of Substantially Equivalent on May 14, 2003, 22 days after the submission was received.
What is the product code of K031277?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.