SHERLOCK 3CG TIP POSITIONING SYSTEM, SHERLOCK 3CG TIP POSITIONING SYSTEM STYLET— 510(k) K091324
Substantially EquivalentC.R. Bard, Inc.
FDA 510(k) clearance K091324 for SHERLOCK 3CG TIP POSITIONING SYSTEM, SHERLOCK 3CG TIP POSITIONING SYSTEM STYLET, Substantially Equivalent on 2009-08-07. Applicant: C.R. Bard, Inc.. Device class: 2.
Clearance details
- Applicant
- C.R. Bard, 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
- Salt Lake Ciy,, UT, US
Recent devices under product code LJS
view all- K260929 — Neonav ECG Tip Location System
- K252373 — BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology +6 more
- K252792 — PM2 System with ECGuide Connector
- K243458 — HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301) +5 more
- K251212 — Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)
More clearances from C.R. Bard, Inc.
view all- K253514 — Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220) +2 more
- K254076 — BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit
- K252971 — Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)
- K251864 — Rubber Utility Catheter
- K251186 — Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)
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 →
Recalls naming K091324
K-number listed on FDA's recall record- Z-2658-2026 — CK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741129674 Catheter stylets provide internal reinforcement to aid in catheter placement.
- Z-2075-2020 — BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000025
- Z-2076-2020 — BARD MYPICC KIT 5F Triple-Lumen, Catalog Number CK000026A
- Z-2077-2020 — BARD MYPICC KIT 4F Single-Lumen, Catalog Number CK000276
- Z-2078-2020 — BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000277
- Z-2079-2020 — BARD MYPICC KIT 5F Triple-Lumen, Catalog Number CK000278
- Z-2082-2020 — BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000435
- Z-2047-2015 — PowerPICC SOLO Catheter with Sherlock 3CG TPS Stylet 4F Maximal Barrier Tray with Microintroducer The PowerPICC Solo catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
- Z-2048-2015 — PowerPICC SOLO Catheter with Sherlock 3CG (TPS) Stylet 5F Maximal Barrier Tray with Microintroducer The PowerPICC Solo catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
- Z-2049-2015 — PowerPICC SOLO Catheter with Tip Location System (TLS) Stylet 4F Nurse Full Tray with Microintroducer (with Lidocain) The PowerPICC Solo catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
- Z-2050-2015 — PowerPICC SOLO2 Catheter 4F Maximal Barrier Tray with Microintroducer (Single-Lumen) (Sherlock) The PowerPICC Solo catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K091324.
Data sourced from openFDA. This site is unofficial and independent of the FDA.