The following data is part of a premarket notification filed by Douglas Medical Products Corp. with the FDA for Solo Picc/midline Catheter Kit Models 71924, 71908.
Device ID | K961155 |
510k Number | K961155 |
Device Name: | SOLO PICC/MIDLINE CATHETER KIT MODELS 71924, 71908 |
Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
Applicant | DOUGLAS MEDICAL PRODUCTS CORP. 1840 INDUSTRIAL DR., SUITE 200 Libertyville, IL 60048 |
Contact | Ron Haselhorst |
Correspondent | Ron Haselhorst DOUGLAS MEDICAL PRODUCTS CORP. 1840 INDUSTRIAL DR., SUITE 200 Libertyville, IL 60048 |
Product Code | LJS |
CFR Regulation Number | 880.5970 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-03-22 |
Decision Date | 1996-06-18 |
Summary: | summary |