Atlas FDA

GBS

27 FDA 510(k) clearances · Product code

28 daysmedian time to decision
88 days90th percentile
27clearances measured

FDA profile

Official device name
Catheter, Ventricular, General & Plastic Surgery
Device class
Class I (low risk)
Regulation
21 CFR 878.4200
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
1992: 2 · 1993: 1 · 2003: 1 · 2007: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
ATRIUMS PDR THORACIC CATHETER (K912645)Atrium Medical Corp.1991-09-13
AXIOM ATRAUM WOUND DRAINS (K883887)Axiom, Inc.1989-02-17
INTRODUCTION/DRAINAGE CATHETER & ACCESS (K881873)Sheridan Catheter Corp.1988-05-18
URESIL WOUND DRAIN TROCAR (K880895)Uresil Corp.1988-03-14
NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAP (K880376)Genesis Industries, Inc.1988-02-16
CLOSED CHEST DRAINAGE SET W/SUTURES (K873377)Gish Biomedical, Inc.1987-10-28
AN3000 MAHONEY DRAIN (K872460)H.W. Andersen Products, Inc.1987-07-23
AN3100 MULHOLLAND DRAIN (K872459)H.W. Andersen Products, Inc.1987-07-21
AN3500 WORTH DRAIN (K872457)H.W. Andersen Products, Inc.1987-07-21
HCI ALL PURPOSE DRAIN/CATHETER SET (K870015)Health Care Innovations, Inc.1987-02-06
URESIL STD FLAT/ROUND & FLAT/ROUND SPLIT. SILI/DRA (K863560)Uresil Corp.1986-09-29
THORACIC CATHETER (CHEST DRAINAGE TUBE) (K863142)Sheridan Catheter Corp.1986-08-29
AXIOM TROCAR THORACIC CATHETER (K863247)Axiom Medical, Inc.1986-08-29
OSTEOTOMY DRAINAGE TUBE (K862584)Treace Medical, Inc.1986-08-12
SILICONE SUMP DRAIN (K862767)Sil-Med Corp.1986-08-07
ROUND SUCTION DRAIN (K854418)Sil-Med Corp.1985-11-19
THORO/CATH STRAIGHT THORACIC RIGHT ANGLE (K853131)J. H. Emerson Co.1985-09-05
AXIOM ATRAUM TROCAR CATHETER (K852241)Axiom Medical, Inc.1985-06-14
CHEST CATHETERS/THORACIC CATHETERS (K851048)Medovations, Inc.1985-06-05
SNYDER HEMOVAC WOUND DRAINAGE DEVICES (K843906)Snyder Laboratories, Inc.1984-11-05
AXIOM HYDROMER WOUND DRAINS (K832416)Axiom Medical, Inc.1983-10-31
ARGYLE MEDIASTINAL DRAIN (K822318)Sherwood Medical Co.1982-08-27
SIL-V-UR CHEST CATHETER (K813463)C.R. Bard, Inc.1982-02-12
DISPOSABLE THORACIC CATHETER (K813587)Texas Medical Products, Inc.1982-01-12
DAVOL SILICONE SHEATH SUMP DRAIN (K810158)C.R. Bard, Inc.1981-02-13
STERILE SILICONE TUBING (K810071)Medspec Corp.1981-02-12
ARGYLE SILICONE THORACIC CATHETER (K802318)Sherwood Medical Co.1980-10-23

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Every clearance here is in the API, with alerts when new ones post.