The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Guidant Proximal Seal System, Models Pss-4500 & Ps-4500.
| Device ID | K022880 |
| 510k Number | K022880 |
| Device Name: | GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500 |
| Classification | Clamp, Vascular |
| Applicant | GUIDANT CORP. 3744 MT. DIABLO BLVD. SUITE 305 Lafayette, CA 94549 |
| Contact | Jeff Schakenraad |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2002-08-30 |
| Decision Date | 2002-09-13 |
| Summary: | summary |