Kamar Annulus Dilator + Sizer; Garrett, Cooley, and Debakey Vessel Dilators
FDA 510(k) K030788 · Geister Medizin Technik GmbH
510(k) numberK030788
Submission
- Device name
- Kamar Annulus Dilator + Sizer; Garrett, Cooley, and Debakey Vessel Dilators
- Applicant
- Geister Medizin Technik GmbH
Amsterdam, Nh, NL - Received
- March 12, 2003
- Decision date
- July 12, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| 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 |
| K905159 | Flo-Rester(R) Vessel SizerDWP · Traditional | Bio-Vascular, Inc. | 02/07/1991SE |
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| K982365 | Atraumatic Vascular Clamps, Model #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX Micro Vascular…DXC · Traditional | 04/08/1999SE |
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Questions and answers
When was Kamar Annulus Dilator + Sizer; Garrett, Cooley, and Debakey Vessel Dilators cleared by the FDA?
Kamar Annulus Dilator + Sizer; Garrett, Cooley, and Debakey Vessel Dilators (K030788) received a 510(k) decision of Substantially Equivalent on July 12, 2003, 122 days after the submission was received.
What is the product code of K030788?
The FDA product code is DWP – Dilator, Vessel, Surgical, a Class II (moderate risk) device regulated under 21 CFR 870.4475.