EQUISTREAM LONG-TERM HEMODIALYSIS CATHETERS— 510(k) K090101

Clearance details

Applicant

C.R. Bard, Inc.

Product code

Code MSD

Device class

Class 2

Regulation

21 CFR 876.5540

Advisory panel

Gastroenterology, Urology

Date received

2009-01-15

Decision date

2009-02-10

Decision

Unknown

Clearance type

Special

Location

Salt Lake Ciy,, UT, US

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Death

67

Injury

545

Malfunction

3,661

Total

4,273

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2368-2019 — EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product Code:5905190, 14.5 Fr. Alphacurve Catheter with Standard Kit, 19 cm length, BARD, UDI# 00801741013799Class II·Terminated·Bard Peripheral Vascular Inc·20190531
• Z-2369-2019 — EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product code:5905240, 14.5 Fr. Alphacurve Catheter with Standard Kit, 24cm length, BARD, UDI# 00801741013805Class II·Terminated·Bard Peripheral Vascular Inc·20190531
• Z-2370-2019 — EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product code:5905280, 14.5 Fr. Alphacurve Catheter with Standard Kit, 28cm length, BARD, UDI# 00801741013812Class II·Terminated·Bard Peripheral Vascular Inc·20190531
• Z-2371-2019 — EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903190, 14.5F, Straight ,19cm length, BARD, UDI# 00801741013690Class II·Terminated·Bard Peripheral Vascular Inc·20190531
• Z-2372-2019 — EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903230, 14.5F, Straight ,23cm length, BARD, UDI: 00801741013706Class II·Terminated·Bard Peripheral Vascular Inc·20190531
• Z-2373-2019 — EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903270, 14.5F, Straight ,27cm length, BARD, UDI: 00801741013713Class II·Terminated·Bard Peripheral Vascular Inc·20190531
• Z-2374-2019 — EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903310, 14.5F, Straight ,31cm length, BARD, UDI: 00801741013720Class II·Terminated·Bard Peripheral Vascular Inc·20190531
• Z-2375-2019 — EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5904270, 14.5F, Straight ,27cm length, BARD, UDI: 00801741013775Class II·Terminated·Bard Peripheral Vascular Inc·20190531
• Z-2376-2019 — EQUISTREAM XK Alphacurve Long-Term Hemodialysis Catheter REF/Product code:5915240, 16F, 24cm length, BARD, UDI: 00801741013904Class II·Terminated·Bard Peripheral Vascular Inc·20190531
• Z-2377-2019 — EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913190, 16F, Straight, 19cm length, BARD, UDI: 00801741013836Class II·Terminated·Bard Peripheral Vascular Inc·20190531
• Z-2378-2019 — EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913230, 16F, Straight, 23cm length, BARD, UDI: 00801741013843Class II·Terminated·Bard Peripheral Vascular Inc·20190531
• Z-2379-2019 — EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913270, 16F, Straight, 27cm length, BARD, UDI: 00801741013850Class II·Terminated·Bard Peripheral Vascular Inc·20190531
• Z-2380-2019 — EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913350, 16F, Straight, 35cm length, BARD, UDI: 00801741013874Class II·Terminated·Bard Peripheral Vascular Inc·20190531
• Z-2381-2019 — EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913310, 16F, Straight, 31cm length, BARD, UDI: 00801741013867Class II·Terminated·Bard Peripheral Vascular Inc·20190531
• Z-2382-2019 — EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913420, 16F, Straight, 42cm length, BARD, UDI: 00801741013881Class II·Terminated·Bard Peripheral Vascular Inc·20190531

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K090101.