HEMOSPLIT XK, HEMOSPLIT XK CATHETER, 16FR X 42 CM, KIT; 16FR X 19 CM, KIT WITH MICROINTRODUCER— 510(k) K033294
UnknownC.R. Bard, Inc.
FDA 510(k) clearance K033294 for HEMOSPLIT XK, HEMOSPLIT XK CATHETER, 16FR X 42 CM, KIT; 16FR X 19 CM, KIT WITH MICROINTRODUCER, Unknown on 2003-11-26. Applicant: C.R. Bard, Inc.. Device class: 2.
Clearance details
- Device name as filed
- HEMOSPLIT XK, HEMOSPLIT XK CATHETER, 16FR X 42 CM, KIT;16FR X 19 CM, KIT WITH MICROINTRODUCER
- Applicant
- C.R. Bard, Inc.
- Product code
- Code MSD
- Device class
- Class 2
- Regulation
- 21 CFR 876.5540
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Special
- Location
- Salt Lake City, UT, US
Recent devices under product code MSD
view allMore clearances from C.R. Bard, Inc.
view all- K253514 — Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220) +2 more
- K254076 — BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit
- K252971 — Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)
- K251864 — Rubber Utility Catheter
- K251186 — Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)
Adverse events under product code MSD
product code MSD- Death
- 67
- Injury
- 545
- Malfunction
- 3,661
- Total
- 4,273
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.