Fogarty Vessel Calibrator
FDA 510(k) K902143 · Baxter Healthcare Corp
510(k) numberK902143
Submission
- Device name
- Fogarty Vessel Calibrator
- Applicant
- Baxter Healthcare Corp
Santa Ana, CA, US - Received
- May 15, 1990
- Decision date
- October 16, 1990
- 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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| 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 |
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Questions and answers
When was Fogarty Vessel Calibrator cleared by the FDA?
Fogarty Vessel Calibrator (K902143) received a 510(k) decision of Substantially Equivalent on October 16, 1990, 154 days after the submission was received.
What is the product code of K902143?
The FDA product code is DWP – Dilator, Vessel, Surgical, a Class II (moderate risk) device regulated under 21 CFR 870.4475.