510(k) K000723 ยท KOD Catheter, Urological
HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC)
| Applicant | Rochester Medical Corp., Stewartville MN, US |
| Decision | Substantially Equivalent, May 19, 2000 |
| Received | Mar 6, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000723
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 4, 2026 | C.R. Bard Inc Products that contain the Pericare Wipes:
SureStep Intermittent Catheter Tray
REF:
INTP16
INTS14
INTS14C
INTS16
INTS16C
PEDINTS06
PEDINTS08
PEDINTS10
UDI code:
00801741183300 10801741183307
008017411 Open, Classified |
KOD | None listed |
| Jan 27, 2022 | C.R. Bard Inc BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14C Terminated |
KOD | None listed |
| Jan 27, 2022 | C.R. Bard Inc BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C Terminated |
KOD | None listed |
| Apr 4, 2018 | C.R. Bard, Inc. HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch. MGC3
Product Usage Intermittent catheters are intended for urinary blad Terminated |
EZD | None listed |
| Apr 4, 2018 | C.R. Bard, Inc. Magic 3 Intermittent Catheters- 12 Male - 30 catheters per box, each catheter is packaged in an individual pouch. Urinary catheter. Terminated |
EZD | None listed |
| Apr 4, 2018 | C.R. Bard, Inc. Personal Intermittent Catheters- 16" and 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch, Item Numbers: 50612, 50614, 50616, 50618, 52306, 52308, 52310, 52606, 52 Terminated |
EZD | None listed |
| Sep 3, 2015 | C.R. Bard, Inc. Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip, Product Code 50614. The catheters are packaged in film-to-film pouches and packaged 30 per box.
Used as an Intermitt Terminated |
KOD | None listed |
| Aug 14, 2015 | C.R. Bard, Inc. Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 10 Fr, (30/box), Product Code 51610.
Intermittent catheter. Terminated |
KOD | None listed |
| Aug 14, 2015 | C.R. Bard, Inc. Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 12 Fr, (30/box), Product Code 51612.
Intermittent catheter. Terminated |
KOD | None listed |
| Aug 14, 2015 | C.R. Bard, Inc. Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 14 Fr, (30/box), Product Code 51614.
Intermittent catheter. Terminated |
KOD | None listed |
| Aug 14, 2015 | C.R. Bard, Inc. Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 16 Fr, (30/box), Product Code 51616.
Intermittent catheter. Terminated |
KOD | None listed |
| Aug 14, 2015 | C.R. Bard, Inc. Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the Insertion Supply Kit, Product Code 51614S.
Intermittent catheter. Terminated |
KOD | None listed |
| Mar 16, 2009 | Rochester Medical Corp Magic3 (Intermittent Catheter), Sterile, Uncoated 6 French Pediatric Length REF # 52306
Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976.
Intended for use for bladder managem Terminated |
KOD | None listed |
| Mar 16, 2009 | Rochester Medical Corp Magic3 (Intermittent Catheter), Sterile, Uncoated 8 French Pediatric Length REF 52308
Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976.
Intended for use for bladder managemen Terminated |
KOD | None listed |
| Mar 16, 2009 | Rochester Medical Corp Magic3 (Intermittent Catheter), Sterile. Uncoated 10 French Pediatric Length REF 52310
Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976.
Intended for use for bladder manageme Terminated |
KOD | None listed |
| Mar 16, 2009 | Rochester Medical Corp Magic3 (Intermittent Catheter), Sterile. Hydrophilic 6 French Pediatric Length REF 52606
Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976.
Intended for use for bladder manage Terminated |
KOD | None listed |
| Mar 16, 2009 | Rochester Medical Corp Magic3 (Intermittent Catheter), Sterile. Uncoated 10 French Male Length REF 53310
Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976.
Intended for use for bladder management i Terminated |
KOD | None listed |
| Mar 16, 2009 | Rochester Medical Corp Magic3 (Intermittent Catheter), Sterile. Hydrophilic 8 French Pediatric Length REF 52608
Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976.
Intended for use for bladder manag Terminated |
KOD | None listed |
| Mar 16, 2009 | Rochester Medical Corp Magic3 (Intermittent Catheter), Sterile. Hydrophilic 10 French Pediatric Length REF 52610
Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976.
Intended for use for bladder mana Terminated |
KOD | None listed |
| Mar 16, 2009 | Rochester Medical Corp Magic3 (Intermittent Catheter), Sterile. Hydrophilic 12 French Male Length REF 53612
Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976.
Intended for use for bladder managemen Terminated |
KOD | None listed |
| Mar 16, 2009 | Rochester Medical Corp Magic3 (Intermittent Catheter), Sterile. Hydrophilic 14 French Male Length REF 53614
Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976.
Intended for use for bladder managemen Terminated |
KOD | None listed |
| Mar 16, 2009 | Rochester Medical Corp Magic3 (Intermittent Catheter), Sterile. Hydrophilic 16 French Male Length REF 53616
Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976.
Intended for use for bladder managemen Terminated |
KOD | None listed |
| Mar 16, 2009 | Rochester Medical Corp HydroSil (Intermittent Urethral Catheter), Hydrophilic 12 French Male Length Sample Packs REF#63612SPL
Rochester Medical, Distributed by Rochester Medical Ltd 10 Commerce Way, Lancing West Sussex BN1 Terminated |
KOD | None listed |
| Mar 16, 2009 | Rochester Medical Corp HydroSil (Intermittent Catheter), Hydrophilic 14 French Male Length Sample Packs REF#63614SPL
Rochester Medical, Distributed by Rochester Medical Ltd 10 Commerce Way, Lancing West Sussex BN158TA, Ste Terminated |
KOD | None listed |
| Mar 16, 2009 | Rochester Medical Corp HydroSil (Intermittent Catheter), Hydrophilic 12 French Male Length REF#63612
Rochester Medical, Distributed by Rochester Medical Ltd 10 Commerce Way, Lancing West Sussex BN158TA, Sterile R, Rocheste Terminated |
KOD | None listed |
| Mar 16, 2009 | Rochester Medical Corp HydroSil (Intermittent Catheter) Hydrophilic 14 French Male Length REF#63614
Rochester Medical, Distributed by Rochester Medical Ltd 10 Commerce Way, Lancing West Sussex BN158TA, Sterile R, Rochester Terminated |
KOD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.