The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Micra Introducer Sheath With Hydrophilic Coating.
| Device ID | K132030 |
| 510k Number | K132030 |
| Device Name: | MICRA INTRODUCER SHEATH WITH HYDROPHILIC COATING |
| Classification | Introducer, Catheter |
| Applicant | MEDTRONIC INC. 8200 CORAL SEA STREET MS MVS11 Mounds View, MN 55112 |
| Contact | Chechamma Varughese |
| Correspondent | Chechamma Varughese MEDTRONIC INC. 8200 CORAL SEA STREET MS MVS11 Mounds View, MN 55112 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-01 |
| Decision Date | 2013-09-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169359888 | K132030 | 000 |