Atlas FDA

HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC)

FDA 510(k) clearance K000723 · decided 2000-05-19

Clearance details

K-number
K000723
Device name
HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC)
Applicant
Rochester Medical Corp.
Decision
Substantially Equivalent
Date received
2000-03-06
Decision date
2000-05-19
Days to decision
74 days
Clearance type
Traditional
Product code
KOD
Device class
2
Regulation number
876.5130
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Stewartville, MN, US
Third-party review
No
Expedited review
No

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

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Recalls involving this device

RecordFirmDate
HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box, each catheter recall (Z-1307-2018)C.R. Bard, Inc.2018-04-04
Magic 3 Intermittent Catheters- 12 Male - 30 catheters per box, each catheter is packaged recall (Z-1308-2018)C.R. Bard, Inc.2018-04-04
Personal Intermittent Catheters- 16" and 10" lengths - 30 catheters per box, each catheter recall (Z-1309-2018)C.R. Bard, Inc.2018-04-04
Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip, Product recall (Z-2732-2015)C.R. Bard, Inc.2015-09-03
Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 10 Fr, (30/box), Pro recall (Z-2384-2015)C.R. Bard, Inc.2015-08-14
Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 12 Fr, (30/box), Pro recall (Z-2385-2015)C.R. Bard, Inc.2015-08-14
Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 14 Fr, (30/box), Pro recall (Z-2386-2015)C.R. Bard, Inc.2015-08-14
Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 16 Fr, (30/box), Pro recall (Z-2387-2015)C.R. Bard, Inc.2015-08-14
Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the Insertion Supp recall (Z-2388-2015)C.R. Bard, Inc.2015-08-14
Magic3 (Intermittent Catheter), Sterile, Uncoated 6 French Pediatric Length REF # 52306 Ro recall (Z-1074-2009)Rochester Medical Corp2009-03-16
Magic3 (Intermittent Catheter), Sterile, Uncoated 8 French Pediatric Length REF 52308 Roch recall (Z-1075-2009)Rochester Medical Corp2009-03-16
Magic3 (Intermittent Catheter), Sterile. Uncoated 10 French Pediatric Length REF 52310 Roc recall (Z-1076-2009)Rochester Medical Corp2009-03-16
Magic3 (Intermittent Catheter), Sterile. Hydrophilic 6 French Pediatric Length REF 52606 R recall (Z-1077-2009)Rochester Medical Corp2009-03-16
Magic3 (Intermittent Catheter), Sterile. Uncoated 10 French Male Length REF 53310 Rocheste recall (Z-1078-2009)Rochester Medical Corp2009-03-16
Magic3 (Intermittent Catheter), Sterile. Hydrophilic 8 French Pediatric Length REF 52608 R recall (Z-1079-2009)Rochester Medical Corp2009-03-16
Magic3 (Intermittent Catheter), Sterile. Hydrophilic 10 French Pediatric Length REF 52610 recall (Z-1080-2009)Rochester Medical Corp2009-03-16
Magic3 (Intermittent Catheter), Sterile. Hydrophilic 12 French Male Length REF 53612 Roche recall (Z-1081-2009)Rochester Medical Corp2009-03-16
Magic3 (Intermittent Catheter), Sterile. Hydrophilic 14 French Male Length REF 53614 Roche recall (Z-1082-2009)Rochester Medical Corp2009-03-16
Magic3 (Intermittent Catheter), Sterile. Hydrophilic 16 French Male Length REF 53616 Roche recall (Z-1083-2009)Rochester Medical Corp2009-03-16
HydroSil (Intermittent Urethral Catheter), Hydrophilic 12 French Male Length Sample Packs recall (Z-1084-2009)Rochester Medical Corp2009-03-16
HydroSil (Intermittent Catheter), Hydrophilic 14 French Male Length Sample Packs REF#63614 recall (Z-1085-2009)Rochester Medical Corp2009-03-16
HydroSil (Intermittent Catheter), Hydrophilic 12 French Male Length REF#63612 Rochester Me recall (Z-1086-2009)Rochester Medical Corp2009-03-16
HydroSil (Intermittent Catheter) Hydrophilic 14 French Male Length REF#63614 Rochester Med recall (Z-1087-2009)Rochester Medical Corp2009-03-16

PMA approvals by this applicant

RecordFirmDate
FEMSOFT URETHRAL INSERT (P990002/S002)Rochester Medical Corp.2013-03-21
FEMSOFT URETHRAL INSERT (P990002/S001)Rochester Medical Corp.2000-12-28
FEMSOFT URETHRAL INSERT (P990002)Rochester Medical Corp.1999-09-30