Graft Marker Ring
FDA 510(k) K001915 · T. Korossurgical Instruments Corp.
510(k) numberK001915
Submission
- Device name
- Graft Marker Ring
- Applicant
- T. Korossurgical Instruments Corp.
Moorepark, CA, US - Received
- June 23, 2000
- Decision date
- April 27, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MAB – Marker, Cardiopulmonary Bypass (Vein Marker)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3450
- Specialty
- Cardiovascular
Other 510(k)s with product code MAB
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Questions and answers
When was Graft Marker Ring cleared by the FDA?
Graft Marker Ring (K001915) received a 510(k) decision of Substantially Equivalent on April 27, 2001, 308 days after the submission was received.
What is the product code of K001915?
The FDA product code is MAB – Marker, Cardiopulmonary Bypass (Vein Marker), a Class II (moderate risk) device regulated under 21 CFR 870.3450.