Marker, Cardiopulmonary Bypass (Vein Marker)
The Cardiopulmonary Bypass Vein Marker (product code MAB) is a cardiovascular surgical instrument used to mark or identify venous structures such as the saphenous vein prior to or during coronary artery bypass graft surgery, ensuring accurate vessel identification and harvesting. Regulated under 21 CFR 870.3450 and classified as a Class 2 device, it requires a 510(k) premarket notification and falls under the Cardiovascular specialty. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- MAB
- Device Class
- FDA class 2
- Regulation Number
- 870.3450
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
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 |
|---|---|---|---|---|
| K052642 | SUTURING WASHER | Jan 17, 2006 | Substantially Equivalent | First Call, Inc. |
| K001915 | GRAFT MARKER RING | Apr 27, 2001 | Substantially Equivalent | T. Korossurgical Instruments Corp. |
| K894268 | C.A.B. RING | Aug 17, 1989 | Substantially Equivalent | Medi-Sharp, Inc. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.