Implantable Endocardial Pacing Leads
FDA 510(k) K831926 · Oscor, Inc.
510(k) numberK831926
Submission
- Device name
- Implantable Endocardial Pacing Leads
- Applicant
- Oscor, Inc.
Palm Harbor, FL, US - Received
- June 15, 1983
- Decision date
- March 12, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DTG – Magnet, Test, Pacemaker
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 870.3690
- Specialty
- Cardiovascular
Other 510(k)s with product code DTG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K092364 | Model 220 Patient MagnetDTG · Traditional | Cyberonics, Inc. | 11/03/2009SE |
| K960849 | Magno AlarmDTG · Traditional | Cardiac Assist Devices, Inc. | 03/26/1997SE |
| K895110 | Maestro Pacemaker Test MagnetDTG · Traditional | Cardiac Control Systems, Inc. | 09/26/1989SE |
| K813153 | Test MagnetDTG · Traditional | Pacesetter Systems | 12/02/1981SE |
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Questions and answers
When was Implantable Endocardial Pacing Leads cleared by the FDA?
Implantable Endocardial Pacing Leads (K831926) received a 510(k) decision of Substantially Equivalent on March 12, 1984, 271 days after the submission was received.
What is the product code of K831926?
The FDA product code is DTG – Magnet, Test, Pacemaker, a Class I (low risk) device regulated under 21 CFR 870.3690.