510(k) K011557
K011557 is an FDA 510(k) premarket notification submitted by NuMED, Inc. for the device "PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS". The FDA issued a decision of Substantially Equivalent on July 12, 2001. The device falls under product code DXF (Catheter, Septostomy), a Class II device regulated under 21 CFR 870.5175. NuMED, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 12, 2001
- Date Received
- May 21, 2001
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Septostomy
- Device Class
- Class II
- Regulation Number
- 870.5175
- Review Panel
- CV
- Submission Type