510(k) Report

510(k) · Cleared

Recalled · 2003

Intergard Knitted Ultra Thin Collagen Coated Vascular Graft and Hemacarotid Patch Ultra Thin

K983819510(k) SpecialCleared Nov 24, 199826-day reviewClass II21 CFR 870.3450Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Intervascular, Inc. · DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

Cleared on Nov 24, 1998 after a 26-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled once.

Decided
Nov 24, 1998
Review
26 days
Class
Class II
Product code
DSY
Recalls
1
Predicates
0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K983819Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DSY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DSY device

  1. #1 K252445 Fusion Bioline Vascular Graftscore 12.4 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Dec 30, 2003Not classifiedZ-0638-04OtherWater permeability of the patch is out of specification.

No ancestor or descendant has a Class I recall.

How does its category compare?

All DSY devices

DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DSY

2in 2025

2007: 12008: 12009: 52010: 42011: 12012: 42013: 52014: 22015: 12016: 12017: 32018: 12019: 12020: 12021: 22022: 22023: 22024: 52025: 22026 (partial year): 1
2007high 5 (2009) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DSY

160in 2024

2009: 73 days median2010: 55 days median2012: 30 days median2013: 69 days median2017: 269 days median2024: 160 days median
2007high 269 (2017) · low 30 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DSY

1in 2025

2009: 22010: 52013: 12016: 22025: 12026 (partial year): 1
2007high 5 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DSY

151in 2025

2007: 1202008: 1642009: 1932010: 1872011: 1652012: 1772013: 2072014: 3522015: 4602016: 2172017: 1932018: 2002019: 2322020: 1692021: 1682022: 1552023: 1492024: 1532025: 151
2007high 460 (2015) · low 120 (2007)2025

MAUDE reports naming product code DSY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—0120
20081—0164
20095732193
20104555187
20111—0165
20124300177
20135691207
20142—0352
20151—0460
20161—2217
201732690193
20181—0200
20191—0232
20201—0169
20212—0168
20222—0155
20232—0149
202451600153
20252—1151
20261—1—

What is it indicated for?

InterGard knitted Ultra Thin collagen coated vascular grafts are indicated for surgical repair, bypass, or replacement of arteries in the treatment of aneurysmal and occlusive disease of the proximal peripheral arteries. Due to the low porosity of the grafts, these products are recommended for use in patients requiring heparinization prior to or during surgery.

The HemaCarotid Patch Ultra Thin is indicated for cardiac and vascular patch graft angioplasty. Due to the low porosity of the fabric, these products are recommended for use in patients requiring heparinization prior to or during surgery.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Intervascular, Inc.

16 FDA decisions under this applicant name. See the company

  • K990800Intergard Knitted Ultra Thin and Intergard Knitted Collagen Coated and Heparin Bonded Vascular ProthesisIntervascular, Inc. · 2001
  • K984294Modification of Intergard Woven Collagen Coated Vascular ProsthesesIntervascular, Inc. · 19991 recall
  • K970843Intergard Woven Collagen Coated Vascular ProsthesesIntervascular, Inc. · 1997
  • K964625Hemapatch Vascular Patches, Intergard and Intergard-RS Vascular ProsthesesIntervascular, Inc. · 19972 recalls
  • K921659Ultra Low Porosity Dacron Woven PatchIntervascular, Inc. · 1992

Recent decisions in DSY

The DSY category page

  • K252445Fusion Bioline Vascular GraftMaquet Cardiovascular, LLC · 2026
  • K252277Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)Vascular Flow Technologies Limited · 2025
  • K241550Gelweave™ Vascular ProsthesesVascutek, Ltd. · 20251 recall
  • K241070Gelsoft™ Plus Vascular ProsthesesVascutek, Ltd. · 20241 recall
  • K231972Advanta VXT Vascular Graft, Flixene Vascular GraftAtrium Medical Corporation · 2024

https://510kreport.com/device/K983819 · printed Nov 6, 2026

Cite this page

510(k) Report. “K983819: Intergard Knitted Ultra Thin Collagen Coated Vascular Graft and Hemacarotid Patch Ultra Thin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983819

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026