Rdi Cardiac Insulation Pad
FDA 510(k) K960312 · R D Intl.
510(k) numberK960312
Submission
- Device name
- Rdi Cardiac Insulation Pad
- Applicant
- R D Intl.
Richardson, TX, US - Received
- January 22, 1996
- Decision date
- April 19, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DWP – Dilator, Vessel, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4475
- Specialty
- Cardiovascular
Other 510(k)s with product code DWP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K220981 | SUPERPLAST Double-Occluder, SUPERPLAST Vascular ProbeDWP · Traditional | Fehling Surgical Instruments, Inc. | 04/20/2023SE |
| K183438 | Geomed Vascular DilatorsDWP · Traditional | Geomed Medizin-Technik GmbH & Co. | 09/03/2019SE |
| K163524 | Vessel DilatorDWP · Traditional | Fetzer Medical GmbH & Co. KG | 06/29/2017SE |
| K130896 | Vascular Probe, Vascular Probe EsDWP · Traditional | Synovis Life Technologies, Inc. | 04/24/2013SE |
| K100518 | Instrumed Vessel Dilators, Model 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054DWP · Traditional | Instrumed International, Inc. | 08/31/2010SE |
| K030788 | Kamar Annulus Dilator + Sizer; Garrett, Cooley, and Debakey Vessel DilatorsDWP · Traditional | Geister Medizin Technik GmbH | 07/12/2003SE |
| K912548 | Lemaitre-Bookwalter Vessel DevicesDWP · Traditional | Vascutech, Inc. | 09/18/1991SE |
| K911475 | Laparoscopic Vessel ArticulatorDWP · Traditional | United States Endoscopy Group, Inc. | 07/02/1991SE |
| K910682 | Robicsek Probe/RetractorDWP · Traditional | Bio-Vascular, Inc. | 05/08/1991SE |
| K905159 | Flo-Rester(R) Vessel SizerDWP · Traditional | Bio-Vascular, Inc. | 02/07/1991SE |
More from Bio-Vascular, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K960937 | Suction Safety DeviceMJJ · Traditional | 06/05/1996SE |
Questions and answers
When was Rdi Cardiac Insulation Pad cleared by the FDA?
Rdi Cardiac Insulation Pad (K960312) received a 510(k) decision of Substantially Equivalent on April 19, 1996, 88 days after the submission was received.
What is the product code of K960312?
The FDA product code is DWP – Dilator, Vessel, Surgical, a Class II (moderate risk) device regulated under 21 CFR 870.4475.