510(k) K972025 ยท KNT Tubes, Gastrointestinal (And Accessories)
RADIUS PULL PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT
| Applicant | Radius Intl., Inc., Tarpon Springs FL, US |
| Decision | Substantially Equivalent, Jan 23, 1998 |
| Received | Jun 2, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972025
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Gauderer Genie* II PEG (Percutaneous Endoscopic Gastrostomy) Safety System Ponsky "Pull" Placement Technique REF 000373, 20F, STERILE. Terminated |
KNT | None listed |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Gauderer Genie* II PEG (Percutaneous Endoscopic Gastrostomy) Safety System Guidewire Placement Technique REF 000375, 20F, STERILE. Terminated |
KNT | None listed |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Ponsky* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - "Pull" REF 003025, 16F, Sterile. Terminated |
KNT | None listed |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Ponsky* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - "Pull" REF 003027, 28F, Sterile. Terminated |
KNT | None listed |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Bard* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - "Guidewire" , REF 003028, 28F, Sterile. Terminated |
KNT | None listed |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., FASTRAC "Pull" Gastric Access Port Kit, REF 005729, 20F, Sterile. Terminated |
KNT | None listed |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., FASTRAC* "Pull" Gastric Access Port Safety System, REF 006033, 20F, Sterile. Terminated |
KNT | None listed |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., FASTRAC* Guidewire Gastric Access Port Safety System, REF 006034, 20F, Sterile. Terminated |
KNT | None listed |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Ponsky* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - "Pull", REF 006035, 20F, Sterile. Terminated |
KNT | None listed |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Safety System, REF 007023, 20F, Sterile. Terminated |
KNT | None listed |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Fastrac* Guidewire Gastric Access Port Safety System, REF 007024, 20F, Sterile. Terminated |
KNT | None listed |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Fastrac* Guidewire Gastric Access Port Safety System, REF 007030, 24F, Sterile. Terminated |
KNT | None listed |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Fastrac* Guidewire Gastric Access Port Safety System, REF 007035, 24F, Sterile. Terminated |
KNT | None listed |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Kit, REF 007036, 24F, Sterile. Terminated |
KNT | None listed |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Kit, REF 007037, 16F, Sterile. Terminated |
KNT | None listed |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Kit, REF 007038, 14F, Sterile. Terminated |
KNT | None listed |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Kit, REF 007050, 24F, Sterile. Terminated |
KNT | None listed |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Safety System, REF 007052, 16F, Sterile. Terminated |
KNT | None listed |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Safety System, REF 007056, 14F, Sterile. Terminated |
KNT | None listed |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Kit, REF 007078, 20F, Sterile. Terminated |
KNT | None listed |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Fastrac* Guidewire Gastric Access Port Kit, REF 007082, 20F, Sterile. Terminated |
KNT | None listed |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Ponsky* Deluxe "Pull" PEG (Percutaneous Endoscopic Gastrostomy) Kit with Soft Silicone Retention Dome, REF 000627, 20F. Terminated |
KNT | None listed |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Bard* Deluxe Guidewire PEG (Percutaneous Endoscopic Gastrostomy) System with Soft Silicone Retention Dome, REF 000628, 20F. Terminated |
KNT | None listed |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Ponsky* Deluxe "Pull" PEG (Percutaneous Endoscopic Gastrostomy) Kit with Soft Silicone Retention Dome, Sterile, Rx only, REF 000792, 20F. Terminated |
KNT | None listed |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Bard* Deluxe Guidewire PEG (Percutaneous Endoscopic Gastrostomy) System with Soft Silicone Retention Dome, Sterile, Rx only, REF 000793, 20F. Terminated |
KNT | None listed |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Ponsky* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - "Pull", REF 003029, 20F, Sterile. Terminated |
KNT | None listed |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Bard* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - "Guidewire" REF 003030, 20F, Sterile. Terminated |
KNT | None listed |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., FASTRAC Guidewire Gastric Access Port Kit, REF 005739, 20F, Sterile. Terminated |
KNT | None listed |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Bard* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - "Guidewire", REF 006036, 20F, Sterile. Terminated |
KNT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.