The following data is part of a premarket notification filed by Primeline Medical Products, Inc. with the FDA for Primagard Nonsterile Femoral Angiography Drapes (models Pm1-0136, Pm1-0119, Pm1-0142).
| Device ID | K021864 |
| 510k Number | K021864 |
| Device Name: | PRIMAGARD NONSTERILE FEMORAL ANGIOGRAPHY DRAPES (MODELS PM1-0136, PM1-0119, PM1-0142) |
| Classification | Drape, Surgical |
| Applicant | PRIMELINE MEDICAL PRODUCTS, INC. 10707 100TH AVE., SUITE 300 Edmonton, Alberta, CA T5j 3m1 |
| Contact | Brenda Lee |
| Correspondent | Brenda Lee PRIMELINE MEDICAL PRODUCTS, INC. 10707 100TH AVE., SUITE 300 Edmonton, Alberta, CA T5j 3m1 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-06 |
| Decision Date | 2002-09-23 |