The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Hemosplit Xk, Hemosplit Xk Catheter, 16fr X 42 Cm, Kit;16fr X 19 Cm, Kit With Microintroducer.
| Device ID | K033294 |
| 510k Number | K033294 |
| Device Name: | HEMOSPLIT XK, HEMOSPLIT XK CATHETER, 16FR X 42 CM, KIT;16FR X 19 CM, KIT WITH MICROINTRODUCER |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | C.R. BARD, INC. 5425 WEST AMELIA EARHART DR. Salt Lake City, UT 84116 |
| Contact | Glenn Norton |
| Correspondent | Glenn Norton C.R. BARD, INC. 5425 WEST AMELIA EARHART DR. Salt Lake City, UT 84116 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-14 |
| Decision Date | 2003-11-26 |
| Summary: | summary |