FDA.report

510(k) K042531

Device
UPDATED SLIP UROLOGY INTRODUCER SHEATH
Applicant
Percutaneous Systems, Incorporated
510(k) number
K042531
Product code
KNY
Decision
Substantially Equivalent (SESE)
Decision date
2005-02-01
Date received
2004-09-17
Regulation
876.5130
Classification name
Accessories, Catheter, G-U
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
THOMAS LAWSON
Address
1300 Crittenden Ln. Suite 301 Mountain View CA US 94043 94043

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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K112209PREFILLED CATHETER INFLATION SYRINGEAvail Medical Products, Inc.2011-09-08
K090121PRE-FILLED CATHETER INFLATION SYRINGEAvail Medical Products, Inc.2009-04-15
K052298CYSTOGLIDE INTRODUCER SHEATHPercutaneous Systems, Incorporated2006-12-12
K062240CAREVENTChief Medical, LLC2006-10-16
K052952CATHASSISTPhysician Technologies, Inc.2006-05-14
K052134CYSTOGLIDE DILATING INTRODUCER SHEATHPercutaneous Systems, Inc.2005-09-22
K051593UROPASS URETERAL ACCESS SHEATH, MODEL 61224Acmi Corporation2005-09-02