The following data is part of a premarket notification filed by Cardiac Pacemakers, Inc. with the FDA for Acuity Break-away Guide Catheter.
| Device ID | K093969 |
| 510k Number | K093969 |
| Device Name: | ACUITY BREAK-AWAY GUIDE CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | CARDIAC PACEMAKERS, INC. 4100 HAMLINE AVE., NORTH St. Paul, MN 55112 -5798 |
| Contact | Kathleen Vittum |
| Correspondent | Kathleen Vittum CARDIAC PACEMAKERS, INC. 4100 HAMLINE AVE., NORTH St. Paul, MN 55112 -5798 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-23 |
| Decision Date | 2010-03-05 |
| Summary: | summary |