FDA.reportPublic FDA data

CVAC Aspiration System

Primary DI
00860005357703
Brand
CVAC Aspiration System
Company
Calyxo, Inc.
Model
CVAC70
Published
2020-12-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FEDEndoscopic Access Overtube, Gastroenterology-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEDEndoscopic Access Overtube, Gastroenterology-UrologyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200419000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200419000Kalera Vacuum Aspiration Catheter (K-VAC)Kalera Medical, Inc.2020-05-22FED

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860005357700PackageGS15Not in Commercial Distribution
20860005357707PackageGS12Not in Commercial Distribution
30860005357704PackageGS13Not in Commercial Distribution
40860005357701PackageGS14Not in Commercial Distribution
00860005357703PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000535770010860005357700
2086000535770720860005357707
3086000535770430860005357704
4086000535770140860005357701
00860005357703008600053577038600053577030860005357703

GMDN Terms#

Term, Definition table
TermDefinition
Intracorporeal lithotripsy suction systemAn assembly of devices designed for use with an intracorporeal lithotripsy system to evacuate, by suction, the irrigation fluid-containing fragments of urinary calculi from the kidneys, ureters, and bladder during lithotripsy. It typically consists of a pneumatically-powered pump that creates suction via the venturi mechanism, a vacuum gauge, vacuum control knob, a compressed air connector, tubing, a moisture filter, and possibly a microbial filter. The vacuum created by the pump is applied to the body through the tubing and an inserted probe, for the removal of the calculi in a stone catcher and the fluid in a collection container.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Working Length70Centimeter

Regulatory Flags#

DUNS number
080269404
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860005357741CVAC Aspiration SystemCVC127020R-12025-09-10
00860005357710CVAC Aspiration SystemCVC127020-12024-02-22
00860005357727CVAC Image ProcessorIMG000020-12024-02-22
20860005357707CVAC Aspiration SystemCVAC702020-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06936345104476Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104483Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104490Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104544Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104551Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104568Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104575Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
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