Left Atrial Appendage Clip, Implantable

FDA product classification. Device class 2. Review panel CV.

Classification

Each row is one field of the openFDA record. The grey name is the field’s name in openFDA’s documentation.

Field	Value	Field name
Product code	PZX	product_code
Device name	Left Atrial Appendage Clip, Implantable	device_name
Device class	2	device_class
Review panel	CV	review_panel
Regulation number	878.4300	regulation_number
Medical specialty	General, Plastic Surgery	medical_specialty

Source: FDA openFDA, device/classification, product code PZX, as held in ArrHub’s controlled vocabulary with its citation. Public domain (CC0).

PMA records with this code

Every verified record ArrHub holds under the code, newest first.

None in the verified view.

510(k) clearances with this code

Every verified record ArrHub holds under the code, newest first.

Decision	Applicant	Device	Record
2026-06-26	Edwards Lifesciences	ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLIPTIS Left Atrial Appendage Exclusion System (ECS145); ECLIPTIS Left Atrial Appendage Exclusion System (ECS150)	K254232 FDA
2026-05-22	Genesee Biomedical, Inc.	ATLAAS (Atraumatic Left Atrial Appendage System) (AD)	K252917 FDA

ArrHub

What ArrHub adds to the record. Everything above this line is the agency’s; everything here is ArrHub’s, dated and attributed.

ArrHub vocabulary

Electrophysiology

PZX is one of the 56 product codes in ArrHub’s electrophysiology vocabulary, each held with its FDA classification record as its citation. Vocabulary entry verified 20 September 2026.

Raw record

The stored record exactly as ArrHub holds it, for anyone who wants to check the page against it.

Show the raw record (JSON)device/classification.json?search=product_code:PZX

{
  "id": "fda_product_code:PZX",
  "vocabulary": "fda_product_code",
  "term": "PZX",
  "definition": "Left Atrial Appendage Clip, Implantable",
  "attrs": {
    "device_class": "2",
    "review_panel": "CV",
    "medical_specialty": "General, Plastic Surgery",
    "regulation_number": "878.4300"
  },
  "jurisdiction": "US",
  "authority": "FDA",
  "ep_relevant": true,
  "source_url": "https://api.fda.gov/device/classification.json?search=product_code:PZX",
  "verified_by": "Bruno Deslauriers",
  "verified_at": "2026-09-20T01:22:27.524165+00:00",
  "notes": "Fetched from https://open.fda.gov/apis/device/classification/",
  "created_at": "2026-09-20T01:19:33.503551+00:00",
  "updated_at": "2026-09-20T01:19:19.213+00:00"
}

The readable page is rendered from the record held in ArrHub’s verified view; the agency record at api.fda.gov governs where they differ.

Links open the agency’s own records. Unlabelled links open web pages. Links marked (JSON) open an agency’s data record, which a browser shows as plain text.

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