The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Ksea Deployable Cardiovascular Clamp.
| Device ID | K014277 |
| 510k Number | K014277 |
| Device Name: | KSEA DEPLOYABLE CARDIOVASCULAR CLAMP |
| Classification | Clamp, Vascular |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | James A Lee |
| Correspondent | James A Lee KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-27 |
| Decision Date | 2002-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551168271 | K014277 | 000 |
| 04048551168257 | K014277 | 000 |
| 04048551168240 | K014277 | 000 |
| 04048551168233 | K014277 | 000 |
| 04048551168226 | K014277 | 000 |
| 04048551168103 | K014277 | 000 |
| 04048551168080 | K014277 | 000 |