The following data is part of a premarket notification filed by Critikon Company,llc with the FDA for Jelco & Cathlon Iv Striped Iv Catheters-radiopagul.
| Device ID | K853701 |
| 510k Number | K853701 |
| Device Name: | JELCO & CATHLON IV STRIPED IV CATHETERS-RADIOPAGUL |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | CRITIKON COMPANY,LLC WEST QUEEN ST. Southington, CT 06489 |
| Contact | Melanie Sabo |
| Correspondent | Melanie Sabo CRITIKON COMPANY,LLC WEST QUEEN ST. Southington, CT 06489 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-04 |
| Decision Date | 1985-10-17 |