510(k) K033936 ยท KNQ Dilator, Esophageal
BARD ELIMINATOR PET BALLOON DILATORS
| Applicant | C.R. Bard, Inc., Billerica MA, US |
| Decision | Substantially Equivalent, Jan 14, 2004 |
| Received | Dec 19, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K033936
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 19, 2007 | Conmed Endoscopic Technologies, Inc. ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 8mm (24 Fr), length 8cm; product code/end item #000341; Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologie Terminated |
KNQ | None listed |
| Jun 19, 2007 | Conmed Endoscopic Technologies, Inc. ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 10mm (30 Fr), length 8cm; product code/end item #000342; Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologi Terminated |
KNQ | None listed |
| Jun 19, 2007 | Conmed Endoscopic Technologies, Inc. ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 12mm (36 Fr), length 8cm; product code/end item #000343 and #000443 (5 pack); Single Use, Non-Sterile; distributed by ConMed Terminated |
KNQ | None listed |
| Jun 19, 2007 | Conmed Endoscopic Technologies, Inc. ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 15mm (45 Fr), length 8cm; product code/end item #000344 and #000735 (5 pack); Single Use, Non-Sterile; distributed by ConMed Terminated |
KNQ | None listed |
| Jun 19, 2007 | Conmed Endoscopic Technologies, Inc. ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 18mm (54 Fr), length 8cm; product code/end item #000345 and #000736 (5 pack); Single Use, Non-Sterile; distributed by ConMed Terminated |
KNQ | None listed |
| Jun 19, 2007 | Conmed Endoscopic Technologies, Inc. ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 20mm (60 Fr), length 8cm; product code/end item #000380 and #000379 (5 pack); Single Use, Non-Sterile; distributed by ConMed Terminated |
KNQ | None listed |
| Jun 19, 2007 | Conmed Endoscopic Technologies, Inc. ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 6mm (18 Fr), length 4cm; product code/end item #000844; Single Use, Non-Sterile; distributed by ConMed Endoscopic Techno Terminated |
KNQ | None listed |
| Jun 19, 2007 | Conmed Endoscopic Technologies, Inc. ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 8mm (24 Fr), length 4cm; product code/end item #000845; Single Use, Non-Sterile; distributed by ConMed Endoscopic Techno Terminated |
KNQ | None listed |
| Jun 19, 2007 | Conmed Endoscopic Technologies, Inc. ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 10mm (30 Fr), length 4cm; product code/end item #000846; Single Use, Non-Sterile; distributed by ConMed Endoscopic Techn Terminated |
KNQ | None listed |
| Jun 19, 2007 | Conmed Endoscopic Technologies, Inc. ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 12mm (36 Fr), length 4cm; product code/end item #000847 and #000857 (5 pack); Single Use, Non-Sterile; distributed by Co Terminated |
KNQ | None listed |
| Jun 19, 2007 | Conmed Endoscopic Technologies, Inc. ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 15mm (45 Fr), length 4cm; product code/end item #000848 and #000858 (5 pack); Single Use, Non-Sterile; distributed by Co Terminated |
KNQ | None listed |
| Jun 19, 2007 | Conmed Endoscopic Technologies, Inc. ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 18mm (54 Fr), length 4cm; product code/end item #000849 and #000859 (5 pack); Single Use, Non-Sterile; distributed by Co Terminated |
KNQ | None listed |
| Jun 19, 2007 | Conmed Endoscopic Technologies, Inc. ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 20mm (60 Fr), length 4cm; product code/end item #000861 and #000867 (5 pack); Single Use, Non-Sterile; distributed by Co Terminated |
KNQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.