Company ยท US
Vital Concepts, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 2003. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
10recalls (0 in 12 months)
10recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 26, 2003 | K032832 | IRRIGATION SETS Vital Concepts, Inc. | HRX |
| May 6, 1996 | K960616 | VITAFLOW SUCTION/ASPIRATION TUBING SET Vital Concepts, Inc. | BYY |
| Mar 2, 1994 | K930192 | VCI INSUFLATOR FILTER W/ TUBING Vital Concepts, Inc. | HIF |
| Feb 1, 1994 | K934382 | VCI SUCTION/IRRIGATION TUBING SET Vital Concepts, Inc. | JOL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | K934382 |
| 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 | K934382 |
| 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 | K934382 |
| 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 | K934382 |
| 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 | K934382 K960616 |
| 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 | K934382 K960616 |
| 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 | K934382 K960616 |
| 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 | K934382 K960616 |
| 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 | K934382 K960616 |
| 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 | K934382 K960616 |