The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Swartz Braided Transseptal Guiding Introducer.
| Device ID | K052644 |
| 510k Number | K052644 |
| Device Name: | SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER |
| Classification | Introducer, Catheter |
| Applicant | ST. JUDE MEDICAL 14901 DEVEAU PL. Minnetonka, MN 55345 -2126 |
| Contact | Glenn Jacques |
| Correspondent | Glenn Jacques ST. JUDE MEDICAL 14901 DEVEAU PL. Minnetonka, MN 55345 -2126 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-26 |
| Decision Date | 2005-12-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414734205832 | K052644 | 000 |
| 05414734205641 | K052644 | 000 |
| 05414734205634 | K052644 | 000 |
| 05414734205627 | K052644 | 000 |
| 05414734205610 | K052644 | 000 |
| 05414734205597 | K052644 | 000 |
| 05414734205580 | K052644 | 000 |
| 05414734205573 | K052644 | 000 |
| 05414734205559 | K052644 | 000 |
| 05414734205542 | K052644 | 000 |
| 05414734205535 | K052644 | 000 |
| 05414734205658 | K052644 | 000 |
| 05414734205672 | K052644 | 000 |
| 05414734205818 | K052644 | 000 |
| 05414734205801 | K052644 | 000 |
| 05414734205795 | K052644 | 000 |
| 05414734205788 | K052644 | 000 |
| 05414734205771 | K052644 | 000 |
| 05414734205764 | K052644 | 000 |
| 05414734205757 | K052644 | 000 |
| 05414734205740 | K052644 | 000 |
| 05414734205733 | K052644 | 000 |
| 05414734205702 | K052644 | 000 |
| 05414734205511 | K052644 | 000 |