Atlas FDA

ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL CATHETER- PICC TRAYS, ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL

FDA 510(k) clearance K974015 · decided 1998-05-18

Clearance details

K-number
K974015
Device name
ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL CATHETER- PICC TRAYS, ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL
Applicant
Davis & Geck, Inc.
Decision
Substantially Equivalent
Date received
1997-10-22
Decision date
1998-05-18
Days to decision
208 days
Clearance type
Traditional
Product code
FOZ
Device class
2
Regulation number
880.5200
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Hazlewood, MO, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Davis & Geck

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
ClearSafe Closed System (K261041)MedSource Labs, LLC2026-07-10
MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV Catheter (K260539)MedSource Labs, LLC2026-07-09
Introcan Safety® Deep Access XL IV Catheter (K253235)B.Braun Medical, Inc.2026-05-15
BD Insyte™ IV Catheter (K252137)Becton Dickinson Infusion Therapy Systems, Inc.2026-04-02
Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm) (K252513)Poly Medicure Limited2026-04-01
SURFLO Hybria Closed System Safety IV Catheter (K252398)Terumo Medical Products (Hangzhou) Co., Ltd.2025-12-17
Polyshield Safety IV Catheters (K252677)Poly Medicure Limited2025-11-05
BD Saf-T-Intima™ Subcutaneous Catheter System (K251422)Becton Dickinson Infusion Therapy Systems, Inc.2025-10-08
BD Nexiva™ Closed IV Catheter System (K243403)Becton Dickinson Infusion Therapy Systems, Inc.2025-07-25
BD Cathena™ Safety IV Catheter (K251155)Becton Dickinson Infusion Therapy Systems, Inc.2025-07-11
BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter (K251654)Becton Dickinson Infusion Therapy Systems, Inc.2025-06-27
BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector (K250682)Becton Dickinson Infusion Therapy Systems, Inc.2025-06-03

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
MAXON AND MAXON CV POLYGLYCONATE MONOFILAMENT ABSORBABLE SURGICAL SUTURE (P840051/S008)Davis & Geck, Inc.1996-11-15
MAXON AND MAXON CV POLYGLYCONATE MONOFILAMENT ABSORBABLE SURGICAL SUTURE (P840051/S007)Davis & Geck, Inc.1996-01-11
NOVAFIL(R) AND VASCUFIL(R) POLYBUTESTER MONOFILAMENT NONABSORBABLE SURGICAL SUTURE (P840041/S006)Davis & Geck, Inc.1996-01-11
NOVAFIL(TM) (P840041/S005)Davis & Geck, Inc.1994-04-20
MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU (P840051/S006)Davis & Geck, Inc.1992-03-24
MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU (P840051/S005)Davis & Geck, Inc.1991-10-17
MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU (P840051/S004)Davis & Geck, Inc.1991-03-29
NOVAFIL(TM) (P840041/S003)Davis & Geck, Inc.1990-07-06