Modification of Bard Quantum CVR, Model H-6770VR
FDA 510(k) K990514 · C.R. Bard, Inc.
510(k) numberK990514
Submission
- Device name
- Modification of Bard Quantum CVR, Model H-6770VR
- Applicant
- C.R. Bard, Inc.
Haverhill, MA, US - Received
- February 18, 1999
- Decision date
- March 9, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DTP – Defoamer, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4230
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
Other 510(k)s with product code DTP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K101186 | Affinity Vard Sub-Assembly for CPS (Carmeda Coated), Purgeline (Uncoated), Holding BagDTP · Traditional | Medtronic Perfusion Systems | 09/03/2010SE |
| K082412 | Venous Bubble Trap, Model VBT 160; Venous Bubble Trap with Bioline Coating, Model Be-Vbt…DTP · Traditional | Mapquet Cardiopulmonary AG | 11/10/2008SE |
| K004046 | Cobe VVR 4000 Filtered Hardshell Venous Reservoir, Cobe Smarxt VVR 4000 Filtered…DTP · Traditional | Cobe Cardiovascular, Inc. | 04/26/2001SE |
| K002591 | Cobe Smarxt VVR 4000 Filtered Hardshell Venous ReservoirDTP · Special | Cobe Cardiovascular, Inc. | 09/13/2000SE |
| K984322 | Dideco D920, Lilliput 1 Twin ReservoirDTP · Traditional | Dideco S.P.A. | 03/02/1999SE |
| K962726 | Bard Quantum CVRDTP · Traditional | C.R. Bard, Inc. | 10/30/1996SE |
| K941654 | Sarns Filtered Venous Reservior ModificationDTP · Traditional | 3M Health Care, Sarns | 07/26/1994SE |
| K933496 | Maxima Filtered Hardshell ReserviorDTP · Traditional | Medtronic Vascular | 10/15/1993SE |
| K912915 | Sarns Non-Filtered Venous ReservoirDTP · Traditional | 3M Health Care, Ltd. | 09/25/1991SE |
| K911789 | Minimax (TM) Hardshell Venous Res W/Inte Card FiltDTP · Traditional | Medtronic Vascular | 08/20/1991SE |
More from Medtronic Vascular
| 510(k) | Device | Decision |
|---|---|---|
| K253514 | Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore…KNT · Traditional | 07/10/2026SE |
| K254076 | BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter KitFCM · Traditional | 05/29/2026SESK |
| K252971 | Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser…GEX · Traditional | 03/17/2026SE |
| K251864 | Rubber Utility CatheterKOD · Traditional | 02/23/2026SE |
| K251186 | Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)LDF · Special | 05/15/2025SE |
| K241334 | Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes…LDF · Traditional | 01/31/2025SE |
| K230356 | Aspirex Thrombectomy SystemQEW · Traditional | 03/31/2023SE |
| K223177 | Highlander 014 PTA Balloon Dilatation CatheterLIT · Traditional | 01/20/2023SE |
| K222793 | WavelinQ GeneratorGEI · Special | 10/17/2022SE |
| K220270 | Aspirex Thrombectomy SystemQEW · Traditional | 06/21/2022SE |
Questions and answers
When was Modification of Bard Quantum CVR, Model H-6770VR cleared by the FDA?
Modification of Bard Quantum CVR, Model H-6770VR (K990514) received a 510(k) decision of Substantially Equivalent on March 9, 1999, 19 days after the submission was received.
What is the product code of K990514?
The FDA product code is DTP – Defoamer, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4230.