Clamp, Vascular, Reprocessed
The Reprocessed Vascular Clamp is a reprocessed cardiovascular surgical instrument used to occlude or control blood flow in blood vessels during vascular surgical procedures; reprocessing validation data must be included in a 510(k) submission. It is classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NMF and regulation 21 CFR 870.4450 in the Cardiovascular specialty. The device is eligible for third-party review and is not an implant or life-sustaining device.
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Basic Information
- Product Code
- NMF
- Device Class
- FDA class 2
- Regulation Number
- 870.4450
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
Definition
Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K120204 | REPROCESSED FEMORAL COMPRESSION DEVICE | Apr 03, 2012 | Substantially Equivalent | Sterilmed, Inc. |
| K012574 | REPROCESSED FEMORAL COMPRESSION DEVICE | Jul 18, 2002 | Substantially Equivalent | Sterilmed, Inc. |
| K011832 | VANGUARD REPROCESSED FEMORAL COMPRESSION DEVICE | Dec 21, 2001 | Substantially Equivalent | Vanguard Medical Concepts, Inc. |