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510(k) K843575

Device
DERBYSHIRE DRAIN
Applicant
SIL-MED CORP.
510(k) number
K843575
Product code
GBW  
Decision
Substantially Equivalent (SESE)
Decision date
1984-10-24
Date received
1984-09-11
Regulation
878.4200
Classification name
Catheter, Peritoneal
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ROBERT BRENNAN
Address
700 Warner Blvd. Taunton MA US 02780 02780

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GBW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K992907INTRADUCERTaut, Inc.1999-10-05
K992904MINI-PORTTaut, Inc.1999-10-05
K972112INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450Taut, Inc.1997-12-01
K961194ANTIMICROBIAL MEDIASTINAL SILICONE DRAINSil-Med Corp.1996-08-08
K960426MEDICOMP FLEXI-SMOOTH WOUND DRAINAGE CATHETERMedical Components, Inc.1996-03-21
K942709MEDIASTINAL SILICONE DRAINSSil-Med Corp.1996-01-04
K933510ARGYLE TURKEL SAFETY TROCAR THORACIC CATHETERSherwood Medical Co.1994-02-24
K926477BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTOCore Dynamics, Inc.1993-11-12
K913733STERILE CHEST TUBEVascular Products, Inc.1991-10-08
K894220HOUTS HYSTERECTOMY DRAINHelix Medical, Inc.1989-08-24
K894119MADEGOM LTDA. PENROSE DRAIN TUBINGMadegom1989-08-18
K854812NELSON-JUNG PLEURAL CATHResearch Medical, Inc.1986-02-11
K813063FLAT DRAINSil-Med Corp.1981-12-18
K811627ARROW PERITONEAL LAVAGE CATHERIZATION KArrow Intl., Inc.1981-08-10
K811378PERCUTANEOUS DRAINING CATHETERMedi-Tech, Inc.1981-06-02

Legacy Summary#

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FDA Review#

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