510(k) K181323
K181323 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "Atlas Gold PTA Dilatation Catheter". The FDA issued a decision of Substantially Equivalent on Aug 3, 2018. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. C.R. Bard, Inc. has 645 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 3, 2018
- Date Received
- May 18, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Angioplasty, Peripheral, Transluminal
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type
- 510(k)