The following data is part of a premarket notification filed by Terumo Medical Corporation with the FDA for Terumo Aspriation Catheter.
| Device ID | K112382 |
| 510k Number | K112382 |
| Device Name: | TERUMO ASPRIATION CATHETER |
| Classification | Catheter, Embolectomy |
| Applicant | Terumo Medical Corporation 950 ELKTON BLVD Elkton, MD 21921 |
| Contact | Daniel R Plonski |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-08-18 |
| Decision Date | 2011-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 74543334177260 | K112382 | 000 |
| 54543334177259 | K112382 | 000 |