MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXX— 510(k) K101784

Clearance details

Applicant

Great Batch Medical

Product code

Code DYB

Device class

Class 2

Regulation

21 CFR 870.1340

Advisory panel

Cardiovascular

Date received

2010-06-25

Decision date

2010-11-26

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Plymouth, MN, US

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• K181855 — RadialSeal Introducer Kit2018-07-26
• K130559 — MOBICATH BI-DIRECTIONAL GUIDING SHEATH2013-05-24
• K122832 — MOBICATH TRANSSEPTAL NEEDLE2012-12-19
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Death

808

Injury

5,922

Malfunction

16,516

Other

5

Total

23,251

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-2914-2016 — CT3Plus (a.k.a. CT3PZ); Catalog number: 7300-0038/ 7300-0038-1. Dermatology: For use in dermatology for incision, excision, ablation, and vaporization with hemostasis of soft tissue; For treatment of fine lines and wrinkles; For mild to moderate inflammatory acne vulgaris; For back acne and atrophic scarring, and; For podiatry, (incision, excision, and coagulation of soft tissue), including. matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neuromasClass II·Terminated·New Star Lasers, Inc.·20160919
• Z-0611-2013 — Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems. The device features adjustable tip geometry through use of a rotating handle to deflect the catheter. This catheter is assembled with a hemostasis valve and a sideport infusion line. The MobiCath Bi-Directional Guiding Sheath is intended for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.Class II·Terminated·Greatbatch Medical·20121112
• Z-0132-2013 — Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems. The device features adjustable tip geometry through use of a rotating handle to deflect the catheter. This catheter is assembled with a hemostasis valve and a sideport infusion line. The MobiCath Bi-Directional Guiding Sheath is intended for introducing various cardiovascular catheters into the heart. Including the left side of the heart through the interatrial septum.Class II·Terminated·Greatbatch Medical·20120924

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K101784.