The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Sterilemed Reprocessed Ivus Imaging Catheter.
| Device ID | K043453 |
| 510k Number | K043453 |
| Device Name: | STERILEMED REPROCESSED IVUS IMAGING CATHETER |
| Classification | Reprocessed Intravascular Ultrasound Catheter |
| Applicant | STERILMED, INC. 11400 73RD AVE. NORTH Maple Grove, MN 55369 |
| Contact | Bruce Lester |
| Correspondent | Bruce Lester STERILMED, INC. 11400 73RD AVE. NORTH Maple Grove, MN 55369 |
| Product Code | OWQ |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-15 |
| Decision Date | 2005-03-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888551044349 | K043453 | 000 |
| 10888551044332 | K043453 | 000 |
| 10888551044325 | K043453 | 000 |
| 10888551044318 | K043453 | 000 |
| 10888551004749 | K043453 | 000 |
| 10888551004732 | K043453 | 000 |
| 10888551004725 | K043453 | 000 |
| 10888551004718 | K043453 | 000 |
| 10888551004701 | K043453 | 000 |