Medtronic Model 5867-1A
FDA 510(k) K852236 · Medtronic Vascular
510(k) numberK852236
Submission
- Device name
- Medtronic Model 5867-1A
- Applicant
- Medtronic Vascular
Minneapolis, MN, US - Received
- May 22, 1985
- Decision date
- July 11, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KFJ – Materials, Repair Or Replacement, Pacemaker
- Device class
- Class III (high risk)
- Regulation
- 21 CFR 870.3710
- Specialty
- Cardiovascular
- Implant
- Yes
Other 510(k)s with product code KFJ
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Questions and answers
When was Medtronic Model 5867-1A cleared by the FDA?
Medtronic Model 5867-1A (K852236) received a 510(k) decision of Substantially Equivalent on July 11, 1985, 50 days after the submission was received.
What is the product code of K852236?
The FDA product code is KFJ – Materials, Repair Or Replacement, Pacemaker, a Class III (high risk) device regulated under 21 CFR 870.3710.