510(k) K960616 ยท BYY Tube, Aspirating, Flexible, Connecting
VITAFLOW SUCTION/ASPIRATION TUBING SET
| Applicant | Vital Concepts, Inc., Grand Rapids MI, US |
| Decision | Substantially Equivalent, May 6, 1996 |
| Received | Feb 13, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K960616
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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.