CHOLANGIOGRAPH BALLOON CATHETER BY J-LLOYD MEDICAL, INC.— 510(k) K974336
Substantially EquivalentJ-Lloyd Medical, Inc.
FDA 510(k) clearance K974336 for CHOLANGIOGRAPH BALLOON CATHETER BY J-LLOYD MEDICAL, INC., Substantially Equivalent on 1998-02-13. Applicant: J-Lloyd Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- J-Lloyd Medical, Inc.
- Product code
- Code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Berlin, NJ, US
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More clearances from J-Lloyd Medical, Inc.
view all- K971504 — HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER
- K973639 — ELECTRODE SEMI-FLOTATION CATHETER BY J-LLOYD MEDICAL, INC.
- K974335 — EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC.
- K963248 — FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P)
- K950440 — DUAL FUNCTION PACING WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD
Adverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.