The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Perm-cath Catheter Kit.
Device ID | K871942 |
510k Number | K871942 |
Device Name: | PERM-CATH CATHETER KIT |
Classification | Catheter, Subclavian |
Applicant | QUINTON, INC. 3303 MONTE VILLA PKWY. Bothell, WA 98021 -8906 |
Contact | Randy Walls |
Correspondent | Randy Walls QUINTON, INC. 3303 MONTE VILLA PKWY. Bothell, WA 98021 -8906 |
Product Code | LFJ |
CFR Regulation Number | 876.5540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-05-19 |
Decision Date | 1987-06-17 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20884521009902 | K871942 | 000 |
20884521009872 | K871942 | 000 |
10884521009882 | K871942 | 000 |
10884521009868 | K871942 | 000 |