The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Radifocus Glidecath (or Radifocus Glidecath Xp).
| Device ID | K090040 |
| 510k Number | K090040 |
| Device Name: | RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP) |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | TERUMO MEDICAL CORP. 950 Elkton Blvd. Elkton, MD 21921 |
| Contact | Mark Unterreiner |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-01-06 |
| Decision Date | 2009-02-06 |
| Summary: | summary |