Wundcath Conduction Catheter
FDA 510(k) K003966 · Micor, Inc.
510(k) numberK003966
Submission
- Device name
- Wundcath Conduction Catheter
- Applicant
- Micor, Inc.
Allison Park, PA, US - Received
- December 22, 2000
- Decision date
- July 17, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRN – Pump, Infusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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More from Deka Research and Development Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K031600 | Conduction CatheterFRN · Traditional | 08/13/2003SE |
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| K001940 | Micor Anesthesia Conduction KitCAZ · Traditional | 08/11/2000SE |
| K991879 | Spring-Wound Epidural CatheterBSO · Traditional | 10/28/1999SE |
| K861008 | Percutaneous CathetersDQY · Traditional | 04/29/1986SE |
| K860339 | Percutaneous CathetersDQY · Traditional | 03/31/1986SE |
| K854018 | Angiography CathetersDQO · Traditional | 01/16/1986SE |
Questions and answers
When was Wundcath Conduction Catheter cleared by the FDA?
Wundcath Conduction Catheter (K003966) received a 510(k) decision of Substantially Equivalent on July 17, 2001, 207 days after the submission was received.
What is the product code of K003966?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.