510(k) K933498
K933498 is an FDA 510(k) premarket notification submitted by Applied Medical Resources for the device "EXTERNAL VEIN STRIPPER". The FDA issued a decision of Substantially Equivalent on March 23, 1994. The device falls under product code DWX (Stripper, Artery, Intraluminal), a Class II device regulated under 21 CFR 870.4875. Applied Medical Resources has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 23, 1994
- Date Received
- July 19, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stripper, Artery, Intraluminal
- Device Class
- Class II
- Regulation Number
- 870.4875
- Review Panel
- CV
- Submission Type