The following data is part of a premarket notification filed by Procedure Products, Inc. with the FDA for Single Use Seldinger/cournand Perc. Ndl.
| Device ID | K810859 |
| 510k Number | K810859 |
| Device Name: | SINGLE USE SELDINGER/COURNAND PERC. NDL |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | PROCEDURE PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-30 |
| Decision Date | 1981-04-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B16097211 | K810859 | 000 |
| B1603118222 | K810859 | 000 |
| B1603118151 | K810859 | 000 |
| B1602293572 | K810859 | 000 |
| B1602118352 | K810859 | 000 |
| B160211827P1 | K810859 | 000 |
| B1602118271 | K810859 | 000 |
| B1602018401 | K810859 | 000 |
| B1602018271 | K810859 | 000 |
| B1602018221 | K810859 | 000 |
| B1603118271 | K810859 | 000 |
| B160311827P1 | K810859 | 000 |
| B1605703871 | K810859 | 000 |
| B1605518291 | K810859 | 000 |
| B1605118271 | K810859 | 000 |
| B16032M18601 | K810859 | 000 |
| B1603293572 | K810859 | 000 |
| B1603293552 | K810859 | 000 |
| B1603121151 | K810859 | 000 |
| B1603118601 | K810859 | 000 |
| B1603118351 | K810859 | 000 |
| B1603118451 | K810859 | 000 |