510(k) K885240
K885240 is an FDA 510(k) premarket notification submitted by Tpl-Cordis, Inc. for the device "MODIFIED ANCOR & HI-FLEX UNIPOLAR ACTIVE FIX. LEAD". The FDA issued a decision of Substantially Equivalent on February 10, 1989. The device falls under product code DTB (Permanent Pacemaker Electrode), a Class III device regulated under 21 CFR 870.3680. Tpl-Cordis, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 10, 1989
- Date Received
- December 21, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Permanent Pacemaker Electrode
- Device Class
- Class III
- Regulation Number
- 870.3680
- Review Panel
- CV
- Submission Type