Minivage(R)
FDA 510(k) K911919 · Autovage
510(k) numberK911919
Submission
- Device name
- Minivage(R)
- Applicant
- Autovage
South Park, PA, US - Received
- April 30, 1991
- Decision date
- July 26, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KDH – Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KDH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K983624 | Giltech Plus Connecting Tube SetKDH · Traditional | Giltech Plus, Inc. | 03/18/1999SE |
| K981286 | Superflow Irrigation and Aspiration Tubing SetsKDH · Traditional | Armm, Inc. | 06/19/1998SE |
| K971259 | Combiport Fluid Lavage DeviceKDH · Traditional | B.Braun Medical, Inc. | 10/27/1997SE |
| K962850 | Tum-E-VacKDH · Traditional | Ethox Corp. | 02/21/1997SE |
| K951533 | Easi-Lav Pediatric / Adult Gastric Lavage KitKDH · Traditional | Ballard Medical Products | 07/05/1995SE |
| K923497 | Flushing Irrigation SetKDH · Traditional | Orion Life Systems, Inc. | 03/21/1994SESK |
| K920619 | Tri-Med Gastric Lavage SystemKDH · Traditional | Tri-Med Specialties, Inc. | 09/04/1992SE |
| K920527 | Tri-Med Quick-Step Gastric Lavage KitKDH · Traditional | Tri-Med Specialties, Inc. | 09/04/1992SE |
| K914908 | Quicvage PlusKDH · Traditional | Autovage | 04/13/1992SESK |
| K914907 | QuicvageKDH · Traditional | Autovage | 01/24/1992SE |
More from Autovage
| 510(k) | Device | Decision |
|---|---|---|
| K922785 | IrrivageEYF · Traditional | 10/16/1992SE |
| K914908 | Quicvage PlusKDH · Traditional | 04/13/1992SESK |
| K914907 | QuicvageKDH · Traditional | 01/24/1992SE |
| K911788 | Econovage RKDH · Traditional | 07/26/1991SE |
| K840943 | Endo-JectBTR · Traditional | 05/25/1984SE |
| K823195 | Gastric Lavage KitKNT · Traditional | 12/03/1982SE |
Questions and answers
When was Minivage(R) cleared by the FDA?
Minivage(R) (K911919) received a 510(k) decision of Substantially Equivalent on July 26, 1991, 87 days after the submission was received.
What is the product code of K911919?
The FDA product code is KDH – Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration, a Class II (moderate risk) device regulated under 21 CFR 876.5980.