# K983162: Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve, Peri-Strips-Strips, Peri-Strips Dry, Vasc

- Pathway: 510(k) (Special)
- Applicant: Bio-Vascular, Inc.
- Decided: Oct 9, 1998 after 29 days
- Product code: FTM (Mesh, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K842066 (1985). 5 ancestors in all.
336 later devices descend from it; 13 cite it directly.
1 of 342 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961811: Peri-Guard Pericardium, Bio-Vascular, Inc. (1996) Summary page 1.
- K842066: Peri-Guard Pericardial Patch, Genetic Laboratories, Inc. (1985) Summary page 1.
- K961810: Supple Peri-Guard Pericardium, Bio-Vascular, Inc. (1996) Summary page 3.
- K921895: Tissue Patch, Tissue Graft, Bio-Vascular, Inc. (1992) Summary page 3.

## Most influential descendants
- K001738: Depuy Restore Orthobiologic Soft Tissue Implant (2000), 173 descendants of its own
- K992537: Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated and Naoh-Treated (2000), 147 descendants of its own
- K014183: Afb (Absorbable Foam Buttress) (2002), 145 descendants of its own
- K030782: Seamguard Bioabsorbable Staple Line Reinforcement Material (2003), 143 descendants of its own
- K032865: Gore Seamguard Bioabsorbable Staple Line Reinforcement Material (2003), 102 descendants of its own

## Recalls of this device
- Feb 28, 2024 · Class II · Z-1378-2024: A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for ce
- Feb 28, 2024 · Class II · Z-1377-2024: A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for ce

## Indications for use
Peri-Guard is intended for repair of pericardial structures and for use as a prosthesis for the surgical repair of soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric binding, muscle flap reinforcement, and hernias (including diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernias). For use as a prosthesis for pericardial closure and soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, and hernias (diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal and umbilical).

Source page: https://510kreport.com/device/K983162
Methodology: https://510kreport.com/methodology