Submission Details
| 510(k) Number | K001408 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 04, 2000 |
| Decision Date | October 30, 2000 |
| Days to Decision | 179 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
KSEA VASCULAR FIBERSCOPES
Oct 2000
Decision
179d
Days
Class 2
Risk
About This 510(k) Submission
K001408 is an FDA 510(k) clearance for the KSEA VASCULAR FIBERSCOPES, a Angioscope (Class II — Special Controls, product code LYK), submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on October 30, 2000, 179 days after receiving the submission on May 4, 2000. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 876.1500.
Device Classification
| Product Code | LYK — Angioscope |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
Manufacturer
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