GRECO-HARVEY SURFACT BOND CATH HYPERALIMENTATION— 510(k) K851243
Substantially EquivalentCook, Inc.
FDA 510(k) clearance K851243 for GRECO-HARVEY SURFACT BOND CATH HYPERALIMENTATION, Substantially Equivalent on 1986-03-14. Applicant: Cook, Inc.. Device class: 2.
Clearance details
- Applicant
- Cook, Inc.
- Product code
- Code LJS
- Device class
- Class 2
- Regulation
- 21 CFR 880.5970
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New Brunswick, NJ, US
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- K251212 — Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)
More clearances from Cook, Inc.
view all- K133130 — BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER
- K140593 — ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE
- K132592 — FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET
- K133597 — CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY
- K131772 — CANTATA(R) 2.9 MICROCATHETER
Adverse events under product code LJS
product code LJS- Death
- 31
- Injury
- 2,791
- Malfunction
- 18,374
- Other
- 5
- Total
- 21,201
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.