Instrumed Vessel Dilators, Model 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054
FDA 510(k) K100518 · Instrumed International, Inc.
510(k) numberK100518
Submission
- Device name
- Instrumed Vessel Dilators, Model 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054
- Applicant
- Instrumed International, Inc.
Schaumburg, IL, US - Received
- February 23, 2010
- Decision date
- August 31, 2010
- 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
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|---|---|---|---|
| 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 |
| 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 |
| K905159 | Flo-Rester(R) Vessel SizerDWP · Traditional | Bio-Vascular, Inc. | 02/07/1991SE |
More from Bio-Vascular, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K100517 | Instrumed Forceps Obsterical, Model# 46-5XXX, Ob-XxxxHDA · Traditional | 04/29/2010SE |
| K092840 | Instrumed Forceps Obstetrical/GynaecologicalHCZ · Traditional | 12/03/2009SE |
| K092544 | Instrumed Vascular ClampsDXC · Traditional | 10/26/2009SE |
| K081651 | Instrumed RongeurHAE · Traditional | 08/08/2008SE |
| K071771 | Instrumed RetractorsGZT · Abbreviated | 08/02/2007SE |
| K040855 | Instrumed Laparoscope and AccessoriesGEI · Traditional | 04/16/2004SE |
Questions and answers
When was Instrumed Vessel Dilators, Model 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 cleared by the FDA?
Instrumed Vessel Dilators, Model 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 (K100518) received a 510(k) decision of Substantially Equivalent on August 31, 2010, 189 days after the submission was received.
What is the product code of K100518?
The FDA product code is DWP – Dilator, Vessel, Surgical, a Class II (moderate risk) device regulated under 21 CFR 870.4475.