Vascular Probe, Vascular Probe Es
FDA 510(k) K130896 · Synovis Life Technologies, Inc.
510(k) numberK130896
Submission
- Device name
- Vascular Probe, Vascular Probe Es
- Applicant
- Synovis Life Technologies, Inc.
St. Paul, MN, US - Received
- April 1, 2013
- Decision date
- April 24, 2013
- 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 |
| 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 |
| K905159 | Flo-Rester(R) Vessel SizerDWP · Traditional | Bio-Vascular, Inc. | 02/07/1991SE |
More from Bio-Vascular, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K223052 | Peri-Guard and Supple Peri-GuardFTM · Traditional | 04/07/2023SE |
| K221032 | Vascu-Guard Vascular Repair PatchPSQ · Traditional | 10/19/2022SE |
| K221029 | PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair PatchPSQ · Traditional | 10/19/2022SE |
| K143589 | GEM Flow COUPLER Device and SystemMVR · Special | 01/16/2015SE |
| K142447 | PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair PatchDXZ · Traditional | 01/07/2015SE |
| K142461 | VASCU-GUARD Peripheral Vascular PatchDXZ · Traditional | 11/25/2014SE |
| K142309 | GEM Flow COUPLER Device and SystemMVR · Special | 09/16/2014SE |
| K132727 | Gem Flow Coupler Device and SystemMVR · Special | 10/22/2013SE |
Questions and answers
When was Vascular Probe, Vascular Probe Es cleared by the FDA?
Vascular Probe, Vascular Probe Es (K130896) received a 510(k) decision of Substantially Equivalent on April 24, 2013, 23 days after the submission was received.
What is the product code of K130896?
The FDA product code is DWP – Dilator, Vessel, Surgical, a Class II (moderate risk) device regulated under 21 CFR 870.4475.