The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Modification To Ultimum Ev Hemostasis Introducer (22f).
| Device ID | K023447 |
| 510k Number | K023447 |
| Device Name: | MODIFICATION TO ULTIMUM EV HEMOSTASIS INTRODUCER (22F) |
| 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 | 2002-10-15 |
| Decision Date | 2002-10-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067009692 | K023447 | 000 |
| 15414734011270 | K023447 | 000 |
| 15414734011256 | K023447 | 000 |
| 15414734011232 | K023447 | 000 |
| 15414734011218 | K023447 | 000 |
| 15414734011195 | K023447 | 000 |
| 15414734011171 | K023447 | 000 |
| 15414734011157 | K023447 | 000 |
| 15414734011133 | K023447 | 000 |
| 15414734011034 | K023447 | 000 |
| 15414734009406 | K023447 | 000 |
| 15414734009390 | K023447 | 000 |
| 15414734009376 | K023447 | 000 |
| 15414734011294 | K023447 | 000 |
| 15414734011317 | K023447 | 000 |
| 15414734011331 | K023447 | 000 |
| 05414734027991 | K023447 | 000 |
| 05414734027717 | K023447 | 000 |
| 05414734021999 | K023447 | 000 |
| 05414734021968 | K023447 | 000 |
| 05414734020930 | K023447 | 000 |
| 15414734013045 | K023447 | 000 |
| 15414734011454 | K023447 | 000 |
| 15414734011430 | K023447 | 000 |
| 15414734011416 | K023447 | 000 |
| 15414734011393 | K023447 | 000 |
| 15414734011379 | K023447 | 000 |
| 15414734011355 | K023447 | 000 |
| 05414734008778 | K023447 | 000 |