Medtronic Model 5028 Target Tip, Bipolar, Implantable, Tined, Ventricular, Transvenous Lead
FDA 510(k) K933731 · Medtronic Vascular
510(k) numberK933731
Submission
- Device name
- Medtronic Model 5028 Target Tip, Bipolar, Implantable, Tined, Ventricular, Transvenous Lead
- Applicant
- Medtronic Vascular
Minneapolis, MN, US - Received
- August 2, 1993
- Decision date
- March 21, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DTB – Permanent Pacemaker Electrode
- Device class
- Class III (high risk)
- Regulation
- 21 CFR 870.3680
- Specialty
- Cardiovascular
- Implant
- Yes
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| K023099 | Arox 45-JBP; Arox 53-JBP; Merox 45-JBP; Merox 53-JBPDTB · Special | Biotronik, Inc. | 10/18/2002SE |
| K021217 | Arox 53-BP; Arox 60-BP; Arox 45-JBP; Arox 53-JBPDTB · Special | Biotronik, Inc. | 05/01/2002SE |
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Questions and answers
When was Medtronic Model 5028 Target Tip, Bipolar, Implantable, Tined, Ventricular, Transvenous Lead cleared by the FDA?
Medtronic Model 5028 Target Tip, Bipolar, Implantable, Tined, Ventricular, Transvenous Lead (K933731) received a 510(k) decision of Substantially Equivalent on March 21, 1994, 231 days after the submission was received.
What is the product code of K933731?
The FDA product code is DTB – Permanent Pacemaker Electrode, a Class III (high risk) device regulated under 21 CFR 870.3680.