Argyle Quick- Picc Peripherally Inserted Central Catheter- Picc Trays, Argyle Quick- Picc Peripherally Inserted Central
by Davis & Geck, Inc. 510(k)
Active
510(k) K974015
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK974015 | Date18 May 1998 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FOZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5200
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 23 Sep 2026
The Argyle Quick-PICC Peripherally Inserted Central Catheter- PICC Trays are sterile, single-use indwelling catheters for venous access. They are inserted via peripheral vein or subclavian cut-down using an introducer, such as a splittable needle or sheath-over-needle. The catheters are designed for temporary venous access and are supplied in trays for clinical use.
The device is intended for use in medical settings and is regulated under FDA 510(k) clearance. It is not reusable and must be discarded after single use. Proper storage and handling are required to maintain sterility until use.
Other devices from Davis & Geck, Inc.
Questions
AI-generated answers, 23 Sep 2026
What is the Argyle Quick-PICC catheter used for?
The Argyle Quick-PICC catheter is a sterile, single-use indwelling catheter designed for temporary venous access. It is inserted via a peripheral vein or subclavian cut-down using an introducer, such as a splittable needle or sheath-over-needle, to provide a pathway for fluids, medications, or blood draws.
How is the device supplied?
The device is supplied in trays for clinical use. These trays are sterile and intended for single use, meaning the entire tray and its contents should be discarded after one procedure to maintain sterility and safety.
Is the Argyle Quick-PICC catheter reusable?
No, the Argyle Quick-PICC catheter is a single-use device. It must be discarded after a single use to prevent the risk of infection and ensure patient safety.
What are the storage requirements for the device?
The device must be stored and handled properly to maintain its sterility until use. It is important to follow the manufacturer's storage instructions to ensure the product remains sterile and effective.