KEDALL 14.5 FR CHRONIC HEMODIALYSIS CATHETER W/SILVER IMPREGNATED SLEEVE (PALINDROME RUBY)— 510(k) K060972
Substantially EquivalentKendall
FDA 510(k) clearance K060972 for KEDALL 14.5 FR CHRONIC HEMODIALYSIS CATHETER W/SILVER IMPREGNATED SLEEVE (PALINDROME RUBY), Substantially Equivalent on 2006-08-04. Applicant: Kendall. Device class: 2.
Clearance details
- Applicant
- Kendall
- Product code
- Code MSD
- Device class
- Class 2
- Regulation
- 21 CFR 876.5540
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mansfield, MA, US
Recent devices under product code MSD
view allMore clearances from Kendall
view all- K092797 — ACUTE AND CHRONIC CATHETER REPAIR KIT
- K062671 — 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATED SLEEVE (PALINDROME SAPPHIRE)
- K053410 — GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR
- K051584 — 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS ACCESSORY
- K043272 — PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER WITH SLOTTED SYMMETRICAL TIP
Adverse events under product code MSD
product code MSD- Death
- 67
- Injury
- 545
- Malfunction
- 3,661
- Total
- 4,273
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 →
Recalls naming K060972
K-number listed on FDA's recall record- Z-1850-2015 — Palindrome SI Chronic Catheter Kit 14.5 Fr x 19cm Item Code: 8888245062 The Palindrome SI Chronic Catheter is indicated for acute and chronic hemodialysis, apheresis, and infusion.
- Z-1851-2015 — Palindrome SI Chronic Catheter Kit 14.5 Fr x 23cm Item Code: 8888245063
- Z-1852-2015 — Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064
- Z-1853-2015 — Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064
- Z-1854-2015 — Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064
- Z-1857-2015 — Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 33 cm Item Code: 8888233508
- Z-1858-2015 — Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145062
- Z-1859-2015 — Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145062C
- Z-1860-2015 — Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063
- Z-1861-2015 — Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063C
- Z-1862-2015 — Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code:8888145064
- Z-1863-2015 — Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064C
- Z-1864-2015 — Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145065
- Z-1865-2015 — Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145065C
- Z-1866-2015 — Palindrome SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066
- Z-1867-2015 — Palindrome SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066C
- Z-1868-2015 — Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145062P
- Z-1869-2015 — Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145062CP
- Z-1870-2015 — Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063P
- Z-1871-2015 — Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063CP
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060972.
Data sourced from openFDA. This site is unofficial and independent of the FDA.