The following data is part of a premarket notification filed by Lake Region Mfg., Inc. with the FDA for Cardiovascular Spring Guides.
| Device ID | K770977 |
| 510k Number | K770977 |
| Device Name: | CARDIOVASCULAR SPRING GUIDES |
| Classification | Wire, Guide, Catheter |
| Applicant | LAKE REGION MFG., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-05-31 |
| Decision Date | 1977-06-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15414734013113 | K770977 | 000 |
| 20884521811192 | K770977 | 000 |
| 20884521004020 | K770977 | 000 |
| 20884521003962 | K770977 | 000 |
| 15414734007969 | K770977 | 000 |
| 15414734010716 | K770977 | 000 |
| 15414734013052 | K770977 | 000 |
| 15414734013076 | K770977 | 000 |
| 15414734013090 | K770977 | 000 |
| 20884521811123 | K770977 | 000 |