The following data is part of a premarket notification filed by Ryder Intl. Corp. with the FDA for Usci Ideal Ptca Kit.
| Device ID | K953522 |
| 510k Number | K953522 |
| Device Name: | USCI IDEAL PTCA KIT |
| Classification | Syringe, Balloon Inflation |
| Applicant | RYDER INTL. CORP. 1588 ROUTE 130 NORTH SUITE C-2 North Brunswick, NJ 08902 |
| Contact | Patricia W Bradstreet |
| Correspondent | Patricia W Bradstreet RYDER INTL. CORP. 1588 ROUTE 130 NORTH SUITE C-2 North Brunswick, NJ 08902 |
| Product Code | MAV |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-27 |
| Decision Date | 1996-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20886333207620 | K953522 | 000 |
| 20886333207613 | K953522 | 000 |