Vital Concepts, Inc.
Crofton, MD, US
Vital Concepts, Inc. appears in FDA device records in Crofton, MD. FDA records list 4 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 10 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Vital Concepts, Inc. between 1994 and 2003. The busiest year on record is 1994, with 2. The most recent is 2003, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 2 |
| 1996 | 1 |
| 2003 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K032832 | IRRIGATION SETS | HRX | Substantially Equivalent | |
| K960616 | VITAFLOW SUCTION/ASPIRATION TUBING SET | BYY | Substantially Equivalent | |
| K930192 | VCI INSUFLATOR FILTER W/ TUBING | HIF | Substantially Equivalent | |
| K934382 | VCI SUCTION/IRRIGATION TUBING SET | JOL | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0261-04 | 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 | The probe may separate from the cannula. | Terminated | ||
| Z-0260-04 | 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 Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. | The probe may separate from the cannula. | Terminated | ||
| Z-0259-04 | 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., Grand Rapids, Michigan. | The probe may separate from the cannula. | Terminated | ||
| Z-0258-04 | 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, Michigan. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. | The probe may separate from the cannula. | Terminated | ||
| Z-0025-04 | 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 Concepts, Inc., Grand Rapids, Michigan. | The suction valve may become stuck in the 'suction on' position under vacuum. | Terminated | ||
| Z-0024-04 | 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 Technologies, L.L.C., Tucson, AZ. | The suction valve may become stuck in the 'suction on' position under vacuum. | Terminated | ||
| Z-0023-04 | 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 | The suction valve may become stuck in the 'suction on' position under vacuum. | Terminated | ||
| Z-0022-04 | 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. | The suction valve may become stuck in the 'suction on' position under vacuum. | Terminated | ||
| Z-0021-04 | 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., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec. | The suction valve may become stuck in the 'suction on' position under vacuum. | Terminated | ||
| Z-0020-04 | 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 Huntington Instruments, Ogden Utah. | The suction valve may become stuck in the 'suction on' position under vacuum. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain