510(k) K083489
K083489 is an FDA 510(k) premarket notification submitted by Pathway Medical Technologies, Inc. for the device "JETSTREAM PATHWAY PC ATHERECTOMY SYSTEM, MODEL OV10300". The FDA issued a decision of Substantially Equivalent on Jan 23, 2009. The device falls under product code MCW (Catheter, Peripheral, Atherectomy), a Class II device regulated under 21 CFR 870.4875. Pathway Medical Technologies, Inc. has 15 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 23, 2009
- Date Received
- Nov 25, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Catheter, Peripheral, Atherectomy
- Device Class
- Class II
- Regulation Number
- 870.4875
- Review Panel
- CV
- Submission Type
- 510(k)