510(k) K934382 ยท JOL Catheter And Tip, Suction
VCI SUCTION/IRRIGATION TUBING SET
| Applicant | Vital Concepts, Inc., Grand Rapids MI, US |
| Decision | Substantially Equivalent, Feb 1, 1994 |
| Received | Sep 9, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934382
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Vital Concepts, Inc. Irrigation aspiration system with double spike tubing and 33 cm probe, latex free, catalog # 55060. Sterile, single use. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michig Terminated |
BYY | None listed |
| Jul 20, 2004 | Vital Concepts, Inc. Irrigation aspiration system for Nexhat Dorsey type pumps with 33 cm probe and tubing, latex free, catalog # 55050. Sterile, single use. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Gran Terminated |
BYY | None listed |
| Jul 20, 2004 | Vital Concepts, Inc. Reorder # Lapkit 3. Contents: 1- 55060 suction/irrigation valve 2- 30012 insufflation tubing set 3- 5010 anti fog solution with sponge. Sterile. single use. Quanta Technologies L.L.C. brand Manuf Terminated |
BYY | None listed |
| Jul 20, 2004 | Vital Concepts, Inc. Auto Suture IRRIVAC MAX Suction irrigation sytem with 5 mm, 33 cm probe with double spike tubing. Sterile, single use. Catalog # 200-20. Tyco/Healthcare/United States Surgical brand Terminated |
BYY | None listed |
| Oct 15, 2003 | Vital Concepts, Inc. Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Hu Terminated |
GCY | None listed |
| Oct 15, 2003 | Vital Concepts, Inc. Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Gr Terminated |
GCY | None listed |
| Oct 15, 2003 | Vital Concepts, Inc. HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Vital Concepts, Inc., Grand Rapids, Michigan. Terminated |
GCY | None listed |
| Oct 15, 2003 | Vital Concepts, Inc. HYDRO-PRO brand Suction-Irrigation System without Probe, Disposable (single use only), sterile, latex free. R-Med Re-Order # 55170R; Distributed by R-Med, Inc., Orgeon, OH Terminated |
GCY | None listed |
| Oct 15, 2003 | Vital Concepts, Inc. Quanta Technologies L.L.C. brand REORDER # LAPKIT 3. Contents 1 -55060 Suction/Irrigation Valve 2- 30012 Insufflation Tubing set 3- 5010 Anti Fog Solution with Sponge.
Manufactured for Quanta Techno Terminated |
GCY | None listed |
| Oct 15, 2003 | Vital Concepts, Inc. Irrigation Aspiration System for Nezhat Dorsey Type Pumps with 33 cm Probe, and Tubing, Disposable (single use only), sterile, latex free. Catalog # 55050. HYDRO-PRO brand labeled as sold by Vital C Terminated |
GCY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.