The following data is part of a premarket notification filed by Innerspace, Inc. with the FDA for Act 11 Mp Ventricular Catheter.
| Device ID | K013005 |
| 510k Number | K013005 |
| Device Name: | ACT 11 MP VENTRICULAR CATHETER |
| Classification | Catheter, Ventricular |
| Applicant | INNERSPACE, INC. 2933 SOUTH PULLMAN ST., SUITE A Santa Ana, CA 92705 |
| Contact | Donald E Bobo |
| Correspondent | Donald E Bobo INNERSPACE, INC. 2933 SOUTH PULLMAN ST., SUITE A Santa Ana, CA 92705 |
| Product Code | HCA |
| CFR Regulation Number | 882.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-06 |
| Decision Date | 2002-03-08 |
| Summary: | summary |