The following data is part of a premarket notification filed by St.jude Medical with the FDA for Fast-cath Hemostasis Introducer And Transseptal Introducer.
| Device ID | K061015 |
| 510k Number | K061015 |
| Device Name: | FAST-CATH HEMOSTASIS INTRODUCER AND TRANSSEPTAL INTRODUCER |
| Classification | Introducer, Catheter |
| Applicant | ST.JUDE MEDICAL 14901 DEVEAU PLACE Minnetonka, MN 55345 |
| Contact | Glenn Jacques |
| Correspondent | Glenn Jacques ST.JUDE MEDICAL 14901 DEVEAU PLACE Minnetonka, MN 55345 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-13 |
| Decision Date | 2006-08-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414734217293 | K061015 | 000 |
| 05414734203036 | K061015 | 000 |
| 05414734203029 | K061015 | 000 |
| 05414734203012 | K061015 | 000 |
| 05414734203005 | K061015 | 000 |
| 05414734202992 | K061015 | 000 |
| 05414734202985 | K061015 | 000 |
| 05414734202978 | K061015 | 000 |
| 05414734202961 | K061015 | 000 |
| 05414734202954 | K061015 | 000 |
| 05414734202947 | K061015 | 000 |
| 05414734202930 | K061015 | 000 |
| 05414734202886 | K061015 | 000 |
| 05414734203043 | K061015 | 000 |
| 05414734203050 | K061015 | 000 |
| 05414734203104 | K061015 | 000 |
| 05414734203616 | K061015 | 000 |
| 05414734203609 | K061015 | 000 |
| 05414734203579 | K061015 | 000 |
| 05414734203562 | K061015 | 000 |
| 05414734203456 | K061015 | 000 |
| 05414734203449 | K061015 | 000 |
| 05414734203395 | K061015 | 000 |
| 05414734203388 | K061015 | 000 |
| 05414734203357 | K061015 | 000 |
| 05414734203340 | K061015 | 000 |
| 05414734203197 | K061015 | 000 |
| 05414734203166 | K061015 | 000 |
| 05414734203555 | K061015 | 000 |