510(k) K921318
K921318 is an FDA 510(k) premarket notification submitted by Siemens-Pacesetter, Inc. for the device "ADAPTING SLEEVE KIT MODEL 4023". The FDA issued a decision of Substantially Equivalent on August 3, 1992. The device falls under product code DTD (Pacemaker Lead Adaptor), a Class II device regulated under 21 CFR 870.3620. Siemens-Pacesetter, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 3, 1992
- Date Received
- March 19, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pacemaker Lead Adaptor
- Device Class
- Class II
- Regulation Number
- 870.3620
- Review Panel
- CV
- Submission Type