Universal Terminal Cap, 3.2MM
FDA 510(k) K913919 · Telectronics Pacing Systems, Inc.
510(k) numberK913919
Submission
- Device name
- Universal Terminal Cap, 3.2MM
- Applicant
- Telectronics Pacing Systems, Inc.
Englewood, CO, US - Received
- September 3, 1991
- Decision date
- December 31, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 Universal Terminal Cap, 3.2MM cleared by the FDA?
Universal Terminal Cap, 3.2MM (K913919) received a 510(k) decision of Substantially Equivalent on December 31, 1991, 119 days after the submission was received.
What is the product code of K913919?
The FDA product code is KFJ – Materials, Repair Or Replacement, Pacemaker, a Class III (high risk) device regulated under 21 CFR 870.3710.