The following data is part of a premarket notification filed by Siemens-pacesetter, Inc. with the FDA for Adapting Sleeve Kit Model 4023.
| Device ID | K921318 |
| 510k Number | K921318 |
| Device Name: | ADAPTING SLEEVE KIT MODEL 4023 |
| Classification | Pacemaker Lead Adaptor |
| Applicant | SIEMENS-PACESETTER, INC. 15900 VALLEY VIEW COURT P.O.BOX 9221 Sylmar, CA 91392 -9221 |
| Contact | Glenn Thompson |
| Correspondent | Glenn Thompson SIEMENS-PACESETTER, INC. 15900 VALLEY VIEW COURT P.O.BOX 9221 Sylmar, CA 91392 -9221 |
| Product Code | DTD |
| CFR Regulation Number | 870.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-19 |
| Decision Date | 1992-08-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414734506441 | K921318 | 000 |