FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

K Number

K953647

Device Name

MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING

Manufacturer

MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.

Date Cleared

1997-05-16

(651 days)

Product Code

LIT

Regulation Number

870.1250

Intended Use

Indications for use have not changed, and are equivalent to those of the predicate devices cited above.

Device Description

Coating is a polymeric balloon mounted on a double lumen shaft, a design commonly referred to as a "Gruntzig style catheter". Proximally the product is fitted with a Y-connector system with two female luer fittings, one for passage of a guide wire, and the other for balloon inflation. The product is coated with Meadox's exclusive hydrophilic coating on the balloon, the tip and distal shaft.

Ask a Question

K Number

K960766

Device Name

MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT

Manufacturer

MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.

Date Cleared

1997-03-19

(387 days)

Product Code

DYF

Regulation Number

870.3450

Intended Use

The ePTFEMEADS Vascular access. Mid-Flex grafts are specifically indicated for vascular --access, as are Stepped grafts which are designed to reduce the risk of steal syndrome. Externerally Supported Grafts are used where kinking and compression resistance are desired.

Device Description

The ePTFEMENOx Vasular Graft is comprised of an expanded polyenced the exterior of the tube. Externally supported grafts have a continuous PTFE spiral support coil wound around a portion of the graft.

Ask a Question

K Number

K962433

Device Name

MEADOX EXXCEL EPTFE VASCULAR GRAFT

Manufacturer

MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.

Date Cleared

1997-03-17

(266 days)

Product Code

DSY

Regulation Number

870.3450

Intended Use

The MEADOX® EXXCEL™ ePTFE Vascular Grafts are designed to repair or replace peripheral arteries and to provide vascular access. Mid-Flex grafts are specifically indicated for vascular access, as are Stepped grafts which are designed to reduce the risk of steal syndrome. Externerally Supported Grafts are used where kinking and compression resistance are desired.

Device Description

The unwrapped version of the MEADOX® EXXCEL" ePTFE Vascular Graft is comprised of an expanded polytetraffuoroethylene (ePTFE) core tube. Externally supported grafts have a continuous PTFE spiral support coil wound around a portion of the graft.

Ask a Question

K Number

K961847

Device Name

HEMASHIELD VANTAGE (VASCULAR GRAFT

Manufacturer

MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.

Date Cleared

1997-01-22

(254 days)

Product Code

DSY

Regulation Number

870.3450

Intended Use

For use in systemic vascular reconstructions, e.g., replacement in the case of aneurysmal or occlusive disease, in the peripheral region.

Device Description

The HEMASHIELD VANTAGE™ Vascular Graft is a woven polyester graft, impregnated with bovine collagen.

Ask a Question

K Number

K962342

Device Name

HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH

Manufacturer

MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.

Date Cleared

1996-09-10

(84 days)

Product Code

DXZ

Regulation Number

870.3470

Intended Use

The HEMASHIELD FINESSE™ Ultra-Thin, Knitted Cardiovascular Patch is indicated for cardiac and vascular patch grafting. The fabric is also recommended for use in patients requiring systemic heparinization prior to, or during, surgery.

Device Description

The HEMASHIELD FINESSE™ Ultra-Thin, Knitted Cardiovascular Patch is a knitted polyester fabric, impregnated with bovine collagen and contains glycerol as a softening agent.

Ask a Question

K Number

K955460

Device Name

MEADOX MEDICALS, INC., EXPANDED & EXTERNALLY SUPPORTED EXPANDED PTFE VASCULAR GRAFT

Manufacturer

MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.

Date Cleared

1996-05-30

(183 days)

Product Code

DSY

Regulation Number

870.3450

Intended Use

The MEADOX® ePTFE Vascular Grafts are designed to repair or replace peripheral arteries and to provide vascular access. Mid-Flex grafts are specifically indicated for vascular access, as are Stepped grafts which are designed to reduce the risk of steal syndrome. Externally Supported Grafts are used where kinking and compression resistance are desired.

Device Description

The ePTFESSENDOS, Vascular Graft is comprised of an expanded polytetrafluoroethylene (ePTFE) core tube reinforced by a multi-filament PTFE yarn helically wound around the exterior of the tube. Externally supported grafts have a continuous PTFE spiral support coil wound around a portion of the graft.

Ask a Question

K Number

K952884

Device Name

NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER

Manufacturer

MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.

Date Cleared

1996-02-21

(243 days)

Product Code

LIT

Regulation Number

870.1250

Intended Use

Device Description

Ask a Question

K Number

K955349

Device Name

HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC

Manufacturer

MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.

Date Cleared

1996-02-14

(85 days)

Product Code

DXZ

Regulation Number

870.3470

Intended Use

Device Description

Ask a Question

K Number

K953298

Device Name

MS CLASSIQUE BALLOON DIATATION CATHETER

Manufacturer

MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.

Date Cleared

1996-02-08

(209 days)

Product Code

LIT

Regulation Number

870.1250

Intended Use

Device Description

Ask a Question

K Number

K954848

Device Name

HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT

Manufacturer

MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.

Date Cleared

1996-02-01

(101 days)

Product Code

MAL, 74M

Regulation Number

870.3450

Intended Use

For use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. which is substantially equivalent to the currently marketed devices.

Device Description

The HEMASHIELD® CARDIOVASCULAR GRAFTS are knitted and woven polyester grafts. impregnated with bovine collagen.

Ask a Question

Search Results

510(k) Data Aggregation