Vascular Clamp
FDA 510(k) K881158 · T. Korossurgical Instruments Corp.
510(k) numberK881158
Submission
- Device name
- Vascular Clamp
- Applicant
- T. Korossurgical Instruments Corp.
Moorepark, CA, US - Received
- March 18, 1988
- Decision date
- June 20, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXC – Clamp, Vascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4450
- Specialty
- Cardiovascular
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|---|---|---|---|
| K262086 | PreludeSYNC Radial Compression DeviceDXC · Special | Merit Medical Systems, Inc. | 07/22/2026SE |
| K260105 | Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsDXC · Traditional | Edwards Lifesciences | 06/05/2026SE |
| K252772 | Arc Adjustable Radial Cuff Compression DeviceDXC · Traditional | Tz Medical, Inc. | 05/22/2026SE |
| K254060 | Life Saving TourniquetDXC · Traditional | TW Medical | 04/03/2026SE |
| K243627 | Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp…DXC · Traditional | Arc Trauma, LLC | 12/31/2025SE |
| K253070 | Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)DXC · Traditional | Medline Industries, LP | 11/20/2025SE |
| K232577 | Radial Compression DeviceDXC · Traditional | Ningbo Dizegens Medical Science Co.,Ltd | 01/18/2024SE |
| K230281 | PicoclampDXC · Traditional | Kono Seisakusho Co., Ltd. | 10/23/2023SE |
| K221661 | Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)DXC · Traditional | Compression Works, Inc. | 03/03/2023SE |
| K230248 | ViolaDXC · Special | Vascular Graft Solutions, Ltd. | 02/28/2023SE |
More from Vascular Graft Solutions, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K001915 | Graft Marker RingMAB · Traditional | 04/27/2001SE |
| K002755 | Non-Absorbing Sternatomy Monofilament SutureLRN · Traditional | 12/04/2000SE |
| K954016 | Videoscope W/Irrigation SheathHRX · Traditional | 01/25/1996SN |
| K953998 | Discetome Tissue AspiratorHRX · Traditional | 12/04/1995SE |
| K954052 | Arthroscopic Grasper, Cup Forceps and CurettesHRX · Traditional | 11/06/1995SN |
| K954014 | Percutaneous Discectomy Cannula SystemHRX · Traditional | 11/06/1995SN |
| K935529 | Cervical Self-Retaining RetractorGZT · Traditional | 03/22/1994SE |
| K931262 | Reusable/Interchangeable Shaft, Endoscopic ScissorGCJ · Traditional | 08/06/1993SE |
| K926585 | Thorocoscopy Self-Retaining RetractorGAD · Traditional | 08/06/1993SE |
| K926583 | Reusable Endoscopic Scissors, Grasper-MonopolarGCJ · Traditional | 08/06/1993SE |
Questions and answers
When was Vascular Clamp cleared by the FDA?
Vascular Clamp (K881158) received a 510(k) decision of Substantially Equivalent on June 20, 1988, 94 days after the submission was received.
What is the product code of K881158?
The FDA product code is DXC – Clamp, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.4450.