FDA.reportPublic FDA data

CVAC Aspiration System

Primary DI
20860005357707
Brand
CVAC Aspiration System
Company
Calyxo, Inc.
Model
CVAC70
Published
2020-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
10860005357700PackageGS15In Commercial Distribution
20860005357707PackageGS12In Commercial Distribution
30860005357704PackageGS13In Commercial Distribution
40860005357701PackageGS14In 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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080269404
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860005357703CVAC Aspiration SystemCVAC702020-12-01
00860005357741CVAC Aspiration SystemCVC127020R-12025-09-10
00860005357710CVAC Aspiration SystemCVC127020-12024-02-22
00860005357727CVAC Image ProcessorIMG000020-12024-02-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884450457372C2 CryoBalloon™Merit Medical Systems, Inc.FED2026-08-21
06973356551462ProxivaShenzhen Trious Medical Technology Co., LtdFED2026-08-18
06973356551479ProxivaShenzhen Trious Medical Technology Co., LtdFED2026-08-18
06973356551493ProxivaShenzhen Trious Medical Technology Co., LtdFED2026-08-18
06973356551509ProxivaShenzhen Trious Medical Technology Co., LtdFED2026-08-18
06973356551660ProxivaShenzhen Trious Medical Technology Co., LtdFED2026-08-18
06973356551677ProxivaShenzhen Trious Medical Technology Co., LtdFED2026-08-18
06973356551684ProxivaShenzhen Trious Medical Technology Co., LtdFED2026-08-18
06973356551691ProxivaShenzhen Trious Medical Technology Co., LtdFED2026-08-18
06973356551707ProxivaShenzhen Trious Medical Technology Co., LtdFED2026-08-18
06973356551714ProxivaShenzhen Trious Medical Technology Co., LtdFED2026-08-18
06973356551738TriousShenzhen Trious Medical Technology Co., LtdFED2026-06-23
06973356551745TriousShenzhen Trious Medical Technology Co., LtdFED2026-06-23
06973356551752TriousShenzhen Trious Medical Technology Co., LtdFED2026-06-23
06973356551769TriousShenzhen Trious Medical Technology Co., LtdFED2026-06-23
06973356551776TriousShenzhen Trious Medical Technology Co., LtdFED2026-06-23
06973356551783TriousShenzhen Trious Medical Technology Co., LtdFED2026-06-23
06936345101536Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345101543Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104469Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
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
06970462547457Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
06970462547464Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
06970462547471Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10