510(k) K842394
K842394 is an FDA 510(k) premarket notification submitted by Cardiac Pacemakers, Inc. for the device "ASTRA 2, ASTRA 3, 4 & 6". The FDA issued a decision of Substantially Equivalent on October 17, 1984. The device falls under product code DXY (Implantable Pacemaker Pulse-Generator), a Class III device regulated under 21 CFR 870.3610. Cardiac Pacemakers, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 17, 1984
- Date Received
- June 19, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implantable Pacemaker Pulse-Generator
- Device Class
- Class III
- Regulation Number
- 870.3610
- Review Panel
- CV
- Submission Type