Submission Details
| 510(k) Number | K031808 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 12, 2003 |
| Decision Date | July 11, 2003 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Special
MEDRAD SWABBABLE VALVE TRANSFER SET
Jul 2003
Decision
29d
Days
Class 2
Risk
About This 510(k) Submission
K031808 is an FDA 510(k) clearance for the MEDRAD SWABBABLE VALVE TRANSFER SET, a Tubing, Fluid Delivery (Class II — Special Controls, product code FPK), submitted by Medrad, Inc. (Indianola, US). The FDA issued a Cleared decision on July 11, 2003, 29 days after receiving the submission on June 12, 2003. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.
Device Classification
| Product Code | FPK — Tubing, Fluid Delivery |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5440 |
Manufacturer
Similar Devices — FPK Tubing, Fluid Delivery
All 63
K131517 · Medrad, Inc. / Bayer Medical Care, Inc.
· Aug 2013
K063114 · Coeur, Inc.
· Feb 2007
K063239 · Hospira, Inc.
· Dec 2006
K052431 · Medtronic Minimed
· Nov 2005
K041178 · E-Z-Em, Inc.
· Jul 2004
K022431 · Medrad, Inc.
· Sep 2002
More from Medrad, Inc.
View all
K133023
· MCW · Aug 2014
K130381
· QEW · Jul 2013
K130637
· MCW · Apr 2013
K122916
· MCW · Oct 2012
K113363
· QEZ · Jun 2012