Il Video 22,21 & II Atomic Spectrophoto-
FDA 510(k) K830149 · Instrumentation Laboratory CO
510(k) numberK830149
Submission
- Device name
- Il Video 22,21 & II Atomic Spectrophoto-
- Applicant
- Instrumentation Laboratory CO
Mchenry, IL, US - Received
- January 17, 1983
- Decision date
- February 28, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DWD – Suction Control, Intracardiac, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4430
- Specialty
- Cardiovascular
Other 510(k)s with product code DWD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K992657 | Ibc VRV, Model 1350DWD · Traditional | International Biophysics Corp. | 02/18/2000SE |
| K920077 | Nikkiso NK PumpDWD · Traditional | International Medical Products, Inc. | 09/29/1993SE |
| K915482 | B-D Ultra-Vue Procedure Needle W/ Westcott Type PTDWD · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 01/07/1992SE |
| K915481 | B-D Ultra-Vue Procedure Needle W/ Chiba Type PointDWD · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 01/07/1992SE |
| K915480 | B-D Ultra-Vue Procedure Needle W/ Spinal Type Pt.DWD · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 01/07/1992SE |
| K905311 | Duraflo II Heparin Treated Suction Wands Var. Mod.DWD · Traditional | Baxter Bentley Laboratories, Inc. | 01/15/1991SE |
| K895427 | Mediseal Suction CanisterDWD · Traditional | Deroyal Industries, Inc. | 01/19/1990SE |
| K864503 | Modified RLV-2100 BDWD · Traditional | American Omni Medical, Inc. | 01/06/1987SE |
| K863593 | Sarns Safety LoopDWD · Traditional | 3M Health Care, Sarns | 11/18/1986SE |
| K862540 | Left Ventricular Vent Valve Model No. GLVDWD · Traditional | Gish Biomedical, Inc. | 08/29/1986SE |
More from Gish Biomedical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K233790 | Acl Top 970 CLJPA · Special | 12/29/2023SE |
| K230852 | HemosIL Chromogenic Factor IXGGP · Traditional | 12/13/2023SE |
| K221359 | ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMJPA · Traditional | 09/29/2023SE |
| K223608 | GEM Premier 7000 with IQM3CHL · Traditional | 08/10/2023SE |
| K223187 | HemosIL Liquid Anti-XaQLU · Traditional | 06/23/2023SE |
| K231031 | ACL TOP Family 70 SeriesGKP · Traditional | 06/21/2023SE |
| K223090 | GEM Premier ChemSTATCGA · Special | 01/27/2023SE |
| K223402 | HemosIL von Willebrand Factor AntigenGGP · Special | 12/09/2022SE |
| K213464 | HemosIL Liquid Anti-XaKFF · Special | 10/04/2022SE |
| K213426 | HemosIL ReadiPlasTinGJS · Traditional | 08/16/2022SE |
Questions and answers
When was Il Video 22,21 & II Atomic Spectrophoto- cleared by the FDA?
Il Video 22,21 & II Atomic Spectrophoto- (K830149) received a 510(k) decision of Substantially Equivalent on February 28, 1983, 42 days after the submission was received.
What is the product code of K830149?
The FDA product code is DWD – Suction Control, Intracardiac, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4430.