Reusable Fogarty Flexible Calibrator
FDA 510(k) K822687 · American Edwards Laboratories
510(k) numberK822687
Submission
- Device name
- Reusable Fogarty Flexible Calibrator
- Applicant
- American Edwards Laboratories
Walker, MI, US - Received
- September 3, 1982
- Decision date
- October 4, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DWP – Dilator, Vessel, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4475
- Specialty
- Cardiovascular
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| K183438 | Geomed Vascular DilatorsDWP · Traditional | Geomed Medizin-Technik GmbH & Co. | 09/03/2019SE |
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| 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 |
| K960312 | Rdi Cardiac Insulation PadDWP · Traditional | R D Intl. | 04/19/1996SE |
| 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 |
More from Bio-Vascular, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K873485 | Edslab (R) Occlusion Balloon CatheterDQY · Traditional | 12/03/1987SE |
| K872596 | Trantec Disposable Pressure TRANS.53-600/F/F30DRS · Traditional | 09/30/1987SE |
| K872529 | Thermodilution Cardiac Output Computer, Mod. COM-2DXG · Traditional | 09/15/1987SE |
| K870444 | Homepro II Volumetric Infusion PumpFRN · Traditional | 04/17/1987SE |
| K864997 | Medtrac VP Volumetric Infusion PumpFRN · Traditional | 02/27/1987SE |
| K864330 | Shear Force GaugeDXE · Traditional | 01/06/1987SE |
| K862724 | Vein Valve CutterDQY · Traditional | 01/02/1987SE |
| K864155 | Modification of Carpentier-Edwards BioprosthesisDTJ · Traditional | 11/20/1986SE |
| K863596 | Chin-Fogarty Inflation DeviceDXT · Traditional | 11/20/1986SE |
| K863986 | Xenon Light Source for Endoscopic ProceduresHRX · Traditional | 10/31/1986SE |
Questions and answers
When was Reusable Fogarty Flexible Calibrator cleared by the FDA?
Reusable Fogarty Flexible Calibrator (K822687) received a 510(k) decision of Substantially Equivalent on October 4, 1982, 31 days after the submission was received.
What is the product code of K822687?
The FDA product code is DWP – Dilator, Vessel, Surgical, a Class II (moderate risk) device regulated under 21 CFR 870.4475.