FDA.reportPublic FDA data

Baylis Med Tech Passport Steerable Sheath

Primary DI
00885672012571
Brand
Baylis Med Tech Passport Steerable Sheath
Company
Oscor Inc.
Model
PSS0709009
Catalog number
PSS0709009
Device description
Passport Steerable Sheath 7F
Published
2023-03-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DYBIntroducer, catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140406000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140406000DESTINO TWIST, STEERABLE GUIDING SHEATHOscor, Inc.2014-04-17DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885672012571PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885672012571008856720125718856720125710885672012571

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes. It is not intended solely for infusion nor to access superselective small vessels, and does not include a transseptal needle. A percutaneous introduction set, shaft visualization electrodes, or haemostatic valve may be supplied with the guide-catheter. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter0
Outer Diameter0

Contacts#

Phone, Email table
PhoneEmail
+1(727)937-2511sales@oscor.com

Regulatory Flags#

DUNS number
101835833
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885672012892Volante™VLT-6.5-45-9-SVLT-6.5-45-9-S2026-05-08
00885672012908Volante™VLT-6.5-45-17-SVLT-6.5-45-17-S2026-05-08
00885672012915Volante™VLT-6.5-55-7-S-SDVLT-6.5-55-7-S-SD2026-05-08
00885672012922Volante™VLT-6.5-55-9-SVLT-6.5-55-9-S2026-05-08
00885672012939Volante™VLT-6.5-55-9-S-PFVLT-6.5-55-9-S-PF2026-05-08
00885672012946Volante™VLT-6.5-55-17-SVLT-6.5-55-17-S2026-05-08
00885672012953Volante™VLT-6.5-90-9-SVLT-6.5-90-9-S2026-05-08
00885672012960Volante™VLT-7-45-9-SVLT-7-45-9-S2026-05-08
00885672012977Volante™VLT-7-45-17-SVLT-7-45-17-S2026-05-08
00885672012984Volante™VLT-7-55-9-SVLT-7-55-9-S2026-05-08
00885672012991Volante™VLT-7-55-9-S-PFVLT-7-55-9-S-PF2026-05-08
00885672013004Volante™VLT-7-55-17-SVLT-7-55-17-S2026-05-08
00885672013011Volante™VLT-7-75-17-SVLT-7-75-17-S2026-05-08
00885672013028Volante™VLT-7-90-9-SVLT-7-90-9-S2026-05-08
00885672013035Volante™VLT-8.5-55-17-SVLT-8.5-55-17-S2026-05-08
00885672013042Volante™VLT-12-90-30-SVLT-12-90-30-S2026-05-08
00885672013059Volante™VLT-13.8-71-39-SVLT-13.8-71-39-S2026-05-08
00885672013066Volante™VLT-14-55-25-SVLT-14-55-25-S2026-05-08
00885672013073Volante™VLT-14-71-25-S-NMVLT-14-71-25-S-NM2026-05-08
00885672013080DiRex™ Steerable SheathM004DSD100M004DSD1002026-03-31

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Primary DI, Brand, Company table
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